Frequencies for enfrep20180221 dataset : by Jean Roth , jroth@nber.org , 22 Feb 2018 Frequencies for producttype variable in enfrep20180221 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 3 1.91 1.91 Devices | 63 40.13 42.04 Drugs | 78 49.68 91.72 Food | 13 8.28 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for eventid variable in enfrep20180221 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 77992 | 64 40.76 40.76 78064 | 1 0.64 41.40 78173 | 1 0.64 42.04 78237 | 1 0.64 42.68 78469 | 2 1.27 43.95 78622 | 1 0.64 44.59 78666 | 1 0.64 45.22 78681 | 1 0.64 45.86 78699 | 1 0.64 46.50 78731 | 1 0.64 47.13 78759 | 2 1.27 48.41 78792 | 1 0.64 49.04 78811 | 1 0.64 49.68 78824 | 2 1.27 50.96 78839 | 1 0.64 51.59 78878 | 10 6.37 57.96 78899 | 1 0.64 58.60 78902 | 1 0.64 59.24 78910 | 1 0.64 59.87 78952 | 1 0.64 60.51 78958 | 1 0.64 61.15 78963 | 1 0.64 61.78 78964 | 2 1.27 63.06 78980 | 3 1.91 64.97 78983 | 2 1.27 66.24 78997 | 1 0.64 66.88 79001 | 1 0.64 67.52 79002 | 2 1.27 68.79 79007 | 1 0.64 69.43 79008 | 1 0.64 70.06 79024 | 2 1.27 71.34 79025 | 1 0.64 71.97 79033 | 1 0.64 72.61 79036 | 1 0.64 73.25 79040 | 1 0.64 73.89 79042 | 1 0.64 74.52 79043 | 2 1.27 75.80 79044 | 1 0.64 76.43 79045 | 1 0.64 77.07 79050 | 5 3.18 80.25 79055 | 4 2.55 82.80 79067 | 1 0.64 83.44 79068 | 3 1.91 85.35 79080 | 1 0.64 85.99 79082 | 1 0.64 86.62 79084 | 1 0.64 87.26 79089 | 1 0.64 87.90 79092 | 1 0.64 88.54 79095 | 2 1.27 89.81 79103 | 1 0.64 90.45 79104 | 1 0.64 91.08 79109 | 2 1.27 92.36 79111 | 1 0.64 92.99 79118 | 1 0.64 93.63 79121 | 2 1.27 94.90 79131 | 1 0.64 95.54 79135 | 1 0.64 96.18 79144 | 1 0.64 96.82 79145 | 1 0.64 97.45 79168 | 1 0.64 98.09 79172 | 1 0.64 98.73 79174 | 1 0.64 99.36 79175 | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for status variable in enfrep20180221 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Ongoing | 152 96.82 96.82 Terminated | 5 3.18 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for recallingfirm variable in enfrep20180221 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- 3M Company - Health Care Business | 2 1.27 1.27 ABH Nature's Products, Inc. | 2 1.27 2.55 ALLERGAN | 1 0.64 3.18 AMEDA, INC. | 1 0.64 3.82 AMERICAN HEALTH PACKAGING | 1 0.64 4.46 Aesculap Implant Systems LLC | 6 3.82 8.28 Arrow International Inc | 3 1.91 10.19 Avid Medical, Inc. | 1 0.64 10.83 B. Braun Medical, Inc. | 10 6.37 17.20 BYL Solutions Inc. | 1 0.64 17.83 Beckman Coulter Inc. | 1 0.64 18.47 Brolite Products Inc | 3 1.91 20.38 C.R. Bard, Inc. | 1 0.64 21.02 Cepheid | 1 0.64 21.66 Cincinnati Sub-Zero Products LLC | 1 0.64 22.29 Coblentz Distributing Inc dba Walnut .. | 1 0.64 22.93 ConforMIS, Inc. | 1 0.64 23.57 Cook Inc. | 5 3.18 26.75 DePuy Orthopaedics, Inc. | 2 1.27 28.03 Exactech, Inc. | 1 0.64 28.66 GE Medical Systems China Co., Ltd. | 2 1.27 29.94 Genentech, Inc. | 1 0.64 30.57 General Mills, Inc | 1 0.64 31.21 Gibson Laboratories LLC | 1 0.64 31.85 Greer Laboratories Inc | 2 1.27 33.12 Hanover Foods Corporation | 1 0.64 33.76 Hetero Labs Limited Unit V | 1 0.64 34.39 Hologic, Inc | 1 0.64 35.03 Improper Goods | 2 1.27 36.31 Kalila Medical | 2 1.27 37.58 Keystone Dental Inc | 1 0.64 38.22 Kingston Pharma LLC | 1 0.64 38.85 LITTLE RAPIDS CORPORATION | 1 0.64 39.49 Magno Humphries Laboratories, Inc | 1 0.64 40.13 Medtronic Neurosurgery | 1 0.64 40.76 Medtronic Sofamor Danek USA Inc | 1 0.64 41.40 OrthoPediatrics Corp | 1 0.64 42.04 Pentax of America Inc | 1 0.64 42.68 Philips Medical Systems (Cleveland) Inc | 1 0.64 43.31 Primus Pharmaceuticals, Inc. | 4 2.55 45.86 Roche Diabetes Care, Inc. | 1 0.64 46.50 Ross Acquisitions Company | 1 0.64 47.13 Sage Products Inc | 64 40.76 87.90 Sanofi Genzyme | 1 0.64 88.54 Saving Sight | 1 0.64 89.17 Siemens Medical Solutions USA, INC | 1 0.64 89.81 Smiths Medical ASD, Inc. | 1 0.64 90.45 Sun Pharmaceutical Industries, Inc. | 1 0.64 91.08 Synthes (USA) Products LLC | 1 0.64 91.72 Synthes USA | 2 1.27 92.99 Teva Pharmaceuticals USA | 1 0.64 93.63 The Compounding Pharmacy of America | 1 0.64 94.27 WEIS MARKETS | 1 0.64 94.90 Webrx dba RxPalace.com | 1 0.64 95.54 Zimmer Biomet, Inc. | 5 3.18 98.73 Zimmer Surgical Inc | 2 1.27 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for address1 variable in enfrep20180221 dataset : Address1 | Freq. Percent Cum. ----------------------------------------+----------------------------------- 1 Dna Way | 1 0.64 0.64 1 General Mills Blvd | 1 0.64 1.27 1 Giralda Farms | 1 0.64 1.91 1000 S 2nd St | 1 0.64 2.55 10100 N Ambassador Dr Ste 200 | 1 0.64 3.18 10210 Genetic Center Dr | 1 0.64 3.82 1040 Manchester St | 1 0.64 4.46 1090 Horsham Rd | 1 0.64 5.10 12011 Mosteller Rd | 1 0.64 5.73 1230 Wilson Dr | 2 1.27 7.01 125 Cremona Dr | 1 0.64 7.64 1301 10th St E Ste A | 1 0.64 8.28 1301 Goshen Pkwy | 1 0.64 8.92 131 Heartland Blvd | 2 1.27 10.19 1486 York St | 1 0.64 10.83 154 Middlesex Tpke | 1 0.64 11.46 16313 Ne Cameron Blvd | 2 1.27 12.74 1800 Pyramid Pl | 1 0.64 13.38 1900 S Park Ave | 3 1.91 15.29 200 W Ohio Ave | 2 1.27 16.56 2273 Larsen Rd | 1 0.64 17.20 2320 NW 66th Ct | 1 0.64 17.83 2400 Bernville Rd | 3 1.91 19.75 250 S Kraemer Blvd | 1 0.64 20.38 2550 John Glenn Ave Ste A | 1 0.64 21.02 270 Prospect Plains Rd | 1 0.64 21.66 28 Crosby Dr | 1 0.64 22.29 2850 Frontier Dr | 1 0.64 22.93 3 Paragon Dr | 1 0.64 23.57 3380 Langley Dr | 1 0.64 24.20 3773 Corporate Pkwy | 6 3.82 28.03 3850 State Route 39 | 1 0.64 28.66 3909 3 Oaks Rd | 64 40.76 69.43 3m Center 2510 Conway Ave , B# 275-5-.. | 2 1.27 70.70 40 Liberty Blvd | 1 0.64 71.34 485 E Half Day Rd Ste 320 | 1 0.64 71.97 5 County Route 42 | 1 0.64 72.61 500 Kendall St | 1 0.64 73.25 501 N Beneva Rd Ste 550 | 1 0.64 73.89 56 E Bell Dr | 5 3.18 77.07 5700 W 23rd Ave | 1 0.64 77.71 595 Miner Rd | 1 0.64 78.34 6216 Highland Place Way Ste 101-A | 1 0.64 78.98 639 Nuway Cir | 2 1.27 80.25 700 Orthopaedic Dr | 2 1.27 81.53 7373 N. Scottsdale Rd., Suite B-200 | 4 2.55 84.08 745 Camden Ave Ste A | 2 1.27 85.35 750 N Daniels Way | 5 3.18 88.54 8195 Industrial Blvd NE | 1 0.64 89.17 8800 SW Commercial St | 1 0.64 89.81 9000 Westmont Dr | 1 0.64 90.45 901 Marcon Blvd | 10 6.37 96.82 904 E Caribbean Dr | 1 0.64 97.45 9115 Hague Rd | 1 0.64 98.09 National Hi-Tech Dev. Zone | 2 1.27 99.36 Unit V (SEZ Unit I in APIIC SEZ) | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for address2 variable in enfrep20180221 dataset : Address2 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 154 98.09 98.09 NO. 19 Changjiang Road | 2 1.27 99.36 Surv. No. 439-441, 458, Polepally Vill. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for city variable in enfrep20180221 dataset : City | Freq. Percent Cum. ---------------------------------+----------------------------------- Allentown | 10 6.37 6.37 Bedford | 1 0.64 7.01 Bloomington | 5 3.18 10.19 Brea | 1 0.64 10.83 Buffalo Grove | 1 0.64 11.46 Burlington | 1 0.64 12.10 Cambridge | 1 0.64 12.74 Campbell | 2 1.27 14.01 Cary | 64 40.76 54.78 Center Valley | 6 3.82 58.60 Cincinnati | 1 0.64 59.24 Cleveland | 1 0.64 59.87 Columbus | 1 0.64 60.51 Covington | 1 0.64 61.15 Cranbury | 1 0.64 61.78 Dover | 2 1.27 63.06 Edgewood | 2 1.27 64.33 Gainesville | 1 0.64 64.97 Gary | 1 0.64 65.61 Goleta | 1 0.64 66.24 Green Bay | 1 0.64 66.88 Hanover | 1 0.64 67.52 Hebron | 1 0.64 68.15 Indianapolis | 1 0.64 68.79 Jadcherla Mandal, Mahaboob Nagar | 1 0.64 69.43 Kansas City | 1 0.64 70.06 Knoxville | 1 0.64 70.70 Lenoir | 2 1.27 71.97 Lexington | 1 0.64 72.61 Madison | 1 0.64 73.25 Malvern | 1 0.64 73.89 Massena | 1 0.64 74.52 Memphis | 1 0.64 75.16 Millersburg | 1 0.64 75.80 Minneapolis | 1 0.64 76.43 Montvale | 1 0.64 77.07 North Wales | 1 0.64 77.71 Palmetto | 1 0.64 78.34 Portland | 2 1.27 79.62 Reading | 3 1.91 81.53 Saint Paul | 2 1.27 82.80 San Diego | 1 0.64 83.44 Sarasota | 1 0.64 84.08 Scottsdale | 4 2.55 86.62 South San Francisco | 1 0.64 87.26 Streamwood | 3 1.91 89.17 Sunbury | 1 0.64 89.81 Sunnyvale | 1 0.64 90.45 Tigard | 1 0.64 91.08 Toano | 1 0.64 91.72 Warsaw | 8 5.10 96.82 West Chester | 3 1.91 98.73 Wuxi | 2 1.27 100.00 ---------------------------------+----------------------------------- Total | 157 100.00 Frequencies for stateprovince variable in enfrep20180221 dataset : State/Provi | nce | Freq. Percent Cum. ------------+----------------------------------- | 3 1.91 1.91 AZ | 4 2.55 4.46 CA | 7 4.46 8.92 FL | 3 1.91 10.83 GA | 1 0.64 11.46 IL | 68 43.31 54.78 IN | 15 9.55 64.33 KY | 2 1.27 65.61 MA | 3 1.91 67.52 MN | 3 1.91 69.43 MO | 1 0.64 70.06 NC | 2 1.27 71.34 NJ | 3 1.91 73.25 NY | 3 1.91 75.16 OH | 6 3.82 78.98 OR | 3 1.91 80.89 PA | 26 16.56 97.45 TN | 2 1.27 98.73 VA | 1 0.64 99.36 WI | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for postalcode variable in enfrep20180221 dataset : Postal Code | Freq. Percent Cum. ------------+----------------------------------- | 3 1.91 1.91 01730-1402 | 1 0.64 2.55 01803-4403 | 1 0.64 3.18 02142-1108 | 1 0.64 3.82 07645-1782 | 1 0.64 4.46 07940-1027 | 1 0.64 5.10 08512-3605 | 1 0.64 5.73 11717-8315 | 2 1.27 7.01 13662-1569 | 1 0.64 7.64 17331-9570 | 1 0.64 8.28 17801-3318 | 1 0.64 8.92 18034-8217 | 6 3.82 12.74 18109-9512 | 10 6.37 19.11 19355-1418 | 1 0.64 19.75 19380-4231 | 2 1.27 21.02 19380-5986 | 1 0.64 21.66 19454-1505 | 1 0.64 22.29 19605-9607 | 3 1.91 24.20 23168-9351 | 1 0.64 24.84 28645-3646 | 2 1.27 26.11 30014-1497 | 1 0.64 26.75 32653-1630 | 1 0.64 27.39 34221-4161 | 1 0.64 28.03 34232-1352 | 1 0.64 28.66 37919-4068 | 1 0.64 29.30 38132-1703 | 1 0.64 29.94 40508-2422 | 1 0.64 30.57 41048-9105 | 1 0.64 31.21 43217-1188 | 1 0.64 31.85 44143-2131 | 1 0.64 32.48 44622-9642 | 2 1.27 33.76 44654-9683 | 1 0.64 34.39 45241-1528 | 1 0.64 35.03 46256-1025 | 1 0.64 35.67 46406-2617 | 1 0.64 36.31 46582-3994 | 2 1.27 37.58 46582-6989 | 5 3.18 40.76 46582-7001 | 1 0.64 41.40 47404-9120 | 5 3.18 44.59 54303-4809 | 1 0.64 45.22 55144-0001 | 2 1.27 46.50 55426-1347 | 1 0.64 47.13 60013-1804 | 64 40.76 87.90 60089-8806 | 1 0.64 88.54 60107-2944 | 3 1.91 90.45 64153-2313 | 1 0.64 91.08 85253 | 4 2.55 93.63 92121-4362 | 1 0.64 94.27 92821-6232 | 1 0.64 94.90 93117-3083 | 1 0.64 95.54 94080-4990 | 1 0.64 96.18 94089-1189 | 1 0.64 96.82 95008-4146 | 2 1.27 98.09 97223-6252 | 1 0.64 98.73 97230-5030 | 2 1.27 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for country variable in enfrep20180221 dataset : Country | Freq. Percent Cum. --------------+----------------------------------- China | 2 1.27 1.27 India | 1 0.64 1.91 United States | 154 98.09 100.00 --------------+----------------------------------- Total | 157 100.00 Frequencies for voluntarymandated variable in enfrep20180221 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- Voluntary: Firm Initiated | 157 100.00 100.00 --------------------------+----------------------------------- Total | 157 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20180221 dataset : Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- E-Mail | 16 10.19 10.19 Letter | 117 74.52 84.71 Other | 1 0.64 85.35 Press Release | 4 2.55 87.90 Telephone | 8 5.10 92.99 Two or more of the following: Email, .. | 11 7.01 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for distributionpattern variable in enfrep20180221 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- ... | 1 0.64 0.64 Algeria, Armenia, Australia, Canada, .. | 1 0.64 1.27 CA, OR, WA | 1 0.64 1.91 CVS Distribution Centers in the follo.. | 1 0.64 2.55 Direct to MA and PA | 2 1.27 3.82 Distributed Nationwide in the USA and.. | 64 40.76 44.59 Distributed domestically to AL, AR, A.. | 2 1.27 45.86 Distributed in 29 states: AZ, CA, CO,.. | 1 0.64 46.50 Distributed in 8 states: CA, IL, MD, .. | 1 0.64 47.13 Distributed throughout the United Sta.. | 2 1.27 48.41 Distributed to 4 hospitals in the fol.. | 3 1.91 50.32 Distributed to CA, DC, DE, FL, GA, IL.. | 1 0.64 50.96 Distributed to the states of AL, AZ &.. | 1 0.64 51.59 Distribution was made to DC, FL, GA, .. | 2 1.27 52.87 Domestic: SC, IL, IN Foreign: None.. | 3 1.91 54.78 International Distribution to:Germany | 1 0.64 55.41 MN, NC | 1 0.64 56.05 Missouri | 1 0.64 56.69 Multiple U.S. States | 2 1.27 57.96 NY | 1 0.64 58.60 Nationally | 1 0.64 59.24 Nationally; US Consignees for this re.. | 2 1.27 60.51 Nationwide | 2 1.27 61.78 Nationwide Distribution. | 3 1.91 63.69 Nationwide in the USA | 3 1.91 65.61 Nationwide in the USA. | 5 3.18 68.79 PA | 1 0.64 69.43 PA, NY | 1 0.64 70.06 Product was shipped to the following .. | 1 0.64 70.70 Product was shipped to the following .. | 1 0.64 71.34 Seventeen sites located in 13 states:.. | 1 0.64 71.97 TN, SC | 1 0.64 72.61 TX, CT, TN, MO, WI, FL, SD, MS, CA, MS | 1 0.64 73.25 TX, GA, PA, UT and Canada | 1 0.64 73.89 US Distribution and Internationally t.. | 1 0.64 74.52 US Distribution to the states of :CA.. | 1 0.64 75.16 US Distribution to the states of : A.. | 1 0.64 75.80 US Nationwide | 1 0.64 76.43 US Nationwide Distribution | 3 1.91 78.34 US Nationwide Distribution in the sta.. | 1 0.64 78.98 US Nationwide Distribution in the sta.. | 1 0.64 79.62 US Nationwide Distribution to IN, MO,.. | 2 1.27 80.89 US Nationwide Distribution. | 10 6.37 87.26 US Nationwide distribution(36 states) | 1 0.64 87.90 US nationwide distribution. | 2 1.27 89.17 USA (nationwide) | 1 0.64 89.81 Worldwide Distribution - US Distribut.. | 1 0.64 90.45 Worldwide Distribution -- USA, Puerto.. | 1 0.64 91.08 Worldwide Distribution in the states .. | 1 0.64 91.72 Worldwide Distribution: US states of.. | 1 0.64 92.36 Worldwide Distribution: US (nationwid.. | 2 1.27 93.63 Worldwide Distribution: US (nationwid.. | 2 1.27 94.90 Worldwide distribution | 1 0.64 95.54 Worldwide distribution - US Nationwi.. | 5 3.18 98.73 were distributed in CA, MN, MO, NC, N.. | 2 1.27 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for recallnumber variable in enfrep20180221 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- | 3 1.91 1.91 B-0356-2018 | 1 0.64 2.55 B-0357-2018 | 1 0.64 3.18 B-0358-2018 | 1 0.64 3.82 D-0342-2018 | 1 0.64 4.46 D-0344-2018 | 1 0.64 5.10 D-0345-2018 | 1 0.64 5.73 D-0346-2018 | 1 0.64 6.37 D-0347-2018 | 1 0.64 7.01 D-0348-2018 | 1 0.64 7.64 D-0349-2018 | 1 0.64 8.28 D-0350-2018 | 1 0.64 8.92 D-0351-2018 | 1 0.64 9.55 D-0352-2018 | 1 0.64 10.19 D-0353-2018 | 1 0.64 10.83 D-0354-2018 | 1 0.64 11.46 D-0355-2018 | 1 0.64 12.10 D-0356-2018 | 1 0.64 12.74 D-0357-2018 | 1 0.64 13.38 D-0358-2018 | 1 0.64 14.01 D-0359-2018 | 1 0.64 14.65 D-0360-2018 | 1 0.64 15.29 D-0361-2018 | 1 0.64 15.92 D-0362-2018 | 1 0.64 16.56 D-0363-2018 | 1 0.64 17.20 D-0364-2018 | 1 0.64 17.83 D-0365-2018 | 1 0.64 18.47 D-0366-2018 | 1 0.64 19.11 D-0367-2018 | 1 0.64 19.75 D-0368-2018 | 1 0.64 20.38 D-0369-2018 | 1 0.64 21.02 D-0370-2018 | 1 0.64 21.66 D-0371-2018 | 1 0.64 22.29 D-0372-2018 | 1 0.64 22.93 D-0373-2018 | 1 0.64 23.57 D-0374-2018 | 1 0.64 24.20 D-0375-2018 | 1 0.64 24.84 D-0376-2018 | 1 0.64 25.48 D-0377-2018 | 1 0.64 26.11 D-0378-2018 | 1 0.64 26.75 D-0379-2018 | 1 0.64 27.39 D-0380-2018 | 1 0.64 28.03 D-0381-2018 | 1 0.64 28.66 D-0382-2018 | 1 0.64 29.30 D-0383-2018 | 1 0.64 29.94 D-0384-2018 | 1 0.64 30.57 D-0385-2018 | 1 0.64 31.21 D-0386-2018 | 1 0.64 31.85 D-0387-2018 | 1 0.64 32.48 D-0388-2018 | 1 0.64 33.12 D-0389-2018 | 1 0.64 33.76 D-0390-2018 | 1 0.64 34.39 D-0391-2018 | 1 0.64 35.03 D-0392-2018 | 1 0.64 35.67 D-0393-2018 | 1 0.64 36.31 D-0394-2018 | 1 0.64 36.94 D-0395-2018 | 1 0.64 37.58 D-0396-2018 | 1 0.64 38.22 D-0397-2018 | 1 0.64 38.85 D-0398-2018 | 1 0.64 39.49 D-0399-2018 | 1 0.64 40.13 D-0400-2018 | 1 0.64 40.76 D-0401-2018 | 1 0.64 41.40 D-0402-2018 | 1 0.64 42.04 D-0403-2018 | 1 0.64 42.68 D-0404-2018 | 1 0.64 43.31 D-0405-2018 | 1 0.64 43.95 D-0406-2018 | 1 0.64 44.59 D-0407-2018 | 1 0.64 45.22 D-0408-2018 | 1 0.64 45.86 D-0409-2018 | 1 0.64 46.50 D-0410-2018 | 1 0.64 47.13 D-0411-2018 | 1 0.64 47.77 D-0413-2018 | 1 0.64 48.41 D-0414-2018 | 1 0.64 49.04 D-0415-2018 | 1 0.64 49.68 D-0416-2018 | 1 0.64 50.32 D-0417-2018 | 1 0.64 50.96 D-0421-2018 | 1 0.64 51.59 F-0796-2018 | 1 0.64 52.23 F-0797-2018 | 1 0.64 52.87 F-0798-2018 | 1 0.64 53.50 F-0800-2018 | 1 0.64 54.14 F-0801-2018 | 1 0.64 54.78 F-0802-2018 | 1 0.64 55.41 F-0810-2018 | 1 0.64 56.05 F-0811-2018 | 1 0.64 56.69 F-0812-2018 | 1 0.64 57.32 F-0813-2018 | 1 0.64 57.96 F-0820-2018 | 1 0.64 58.60 F-0821-2018 | 1 0.64 59.24 F-0822-2018 | 1 0.64 59.87 Z-0486-2018 | 1 0.64 60.51 Z-0562-2018 | 1 0.64 61.15 Z-0563-2018 | 1 0.64 61.78 Z-0564-2018 | 1 0.64 62.42 Z-0565-2018 | 1 0.64 63.06 Z-0566-2018 | 1 0.64 63.69 Z-0567-2018 | 1 0.64 64.33 Z-0568-2018 | 1 0.64 64.97 Z-0569-2018 | 1 0.64 65.61 Z-0570-2018 | 1 0.64 66.24 Z-0571-2018 | 1 0.64 66.88 Z-0572-2018 | 1 0.64 67.52 Z-0573-2018 | 1 0.64 68.15 Z-0574-2018 | 1 0.64 68.79 Z-0575-2018 | 1 0.64 69.43 Z-0576-2018 | 1 0.64 70.06 Z-0577-2018 | 1 0.64 70.70 Z-0578-2018 | 1 0.64 71.34 Z-0579-2018 | 1 0.64 71.97 Z-0580-2018 | 1 0.64 72.61 Z-0581-2018 | 1 0.64 73.25 Z-0591-2018 | 1 0.64 73.89 Z-0592-2018 | 1 0.64 74.52 Z-0593-2018 | 1 0.64 75.16 Z-0594-2018 | 1 0.64 75.80 Z-0595-2018 | 1 0.64 76.43 Z-0596-2018 | 1 0.64 77.07 Z-0597-2018 | 1 0.64 77.71 Z-0598-2018 | 1 0.64 78.34 Z-0599-2018 | 1 0.64 78.98 Z-0600-2018 | 1 0.64 79.62 Z-0601-2018 | 1 0.64 80.25 Z-0602-2018 | 1 0.64 80.89 Z-0603-2018 | 1 0.64 81.53 Z-0604-2018 | 1 0.64 82.17 Z-0605-2018 | 1 0.64 82.80 Z-0606-2018 | 1 0.64 83.44 Z-0607-2018 | 1 0.64 84.08 Z-0608-2018 | 1 0.64 84.71 Z-0609-2018 | 1 0.64 85.35 Z-0612-2018 | 1 0.64 85.99 Z-0613-2018 | 1 0.64 86.62 Z-0614-2018 | 1 0.64 87.26 Z-0615-2018 | 1 0.64 87.90 Z-0616-2018 | 1 0.64 88.54 Z-0617-2018 | 1 0.64 89.17 Z-0618-2018 | 1 0.64 89.81 Z-0619-2018 | 1 0.64 90.45 Z-0620-2018 | 1 0.64 91.08 Z-0621-2018 | 1 0.64 91.72 Z-0622-2018 | 1 0.64 92.36 Z-0623-2018 | 1 0.64 92.99 Z-0624-2018 | 1 0.64 93.63 Z-0625-2018 | 1 0.64 94.27 Z-0626-2018 | 1 0.64 94.90 Z-0627-2018 | 1 0.64 95.54 Z-0628-2018 | 1 0.64 96.18 Z-0629-2018 | 1 0.64 96.82 Z-0630-2018 | 1 0.64 97.45 Z-0631-2018 | 1 0.64 98.09 Z-0632-2018 | 1 0.64 98.73 Z-0633-2018 | 1 0.64 99.36 Z-0634-2018 | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for classification variable in enfrep20180221 dataset : Classification | Freq. Percent Cum. -------------------+----------------------------------- Class I | 8 5.10 5.10 Class II | 137 87.26 92.36 Class III | 9 5.73 98.09 Not Yet Classified | 3 1.91 100.00 -------------------+----------------------------------- Total | 157 100.00 Frequencies for productdescription variable in enfrep20180221 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- #6600 TJ TORTILLA, Net Wt. 50 Lbs | 1 0.64 0.64 . | 2 1.27 1.91 11MM/130 Degree Titanium Trochanteric.. | 1 0.64 2.55 3M Bair Hugger(M) Normothermia System.. | 1 0.64 3.18 3M Bair Hugger(M) Normothermia System.. | 1 0.64 3.82 A.T.S. 2200TS Tourniquet Systems, Per.. | 1 0.64 4.46 A.T.S. 4000TS Tourniquet Systems, Per.. | 1 0.64 5.10 AGC 2000 LP Patella, labeled as AGC P.. | 1 0.64 5.73 AGC 2000 LP Patella, labeled as AGC P.. | 1 0.64 6.37 ARROW PICC powered by ARROW VPS Style.. | 1 0.64 7.01 AVID Medical QA Pack AV10654-10 | 1 0.64 7.64 Accu-Chek Connect Diabetes Management.. | 1 0.64 8.28 Allergenic Extracts | 1 0.64 8.92 Aripiprazole Tablets, USP, 10 mg, 100.. | 1 0.64 9.55 ArrowADVANTAGE 5 Pressure Injectable .. | 1 0.64 10.19 Arthri-D 120ct | 1 0.64 10.83 Artis oneFloor-mounted system for unc.. | 1 0.64 11.46 Azelastine HCl Nasal Solution (Nasal .. | 1 0.64 12.10 BARD(R) CRITICORE(R) MONITOR, Model: .. | 1 0.64 12.74 BROLITE PRODUCT #5015 SPONGE AND DOUG.. | 1 0.64 13.38 BROLITE PRODUCT #6109 BREAD FLAVOR R,.. | 1 0.64 14.01 Blastomyces dermatitidis Antiserum 1 .. | 1 0.64 14.65 BlockAid Cut Resistant Surgical Glove.. | 1 0.64 15.29 BonaDur For Men (lidocaine) spray, 10.. | 1 0.64 15.92 Bull Capsules, 1800 mg/grain, 30 coun.. | 1 0.64 16.56 CORAIL COXA VARA HIGH OFFSET STEM Col.. | 1 0.64 17.20 CORAIL HIGH OFFSET STEM Collarless SI.. | 1 0.64 17.83 Carestation 620 A1, Carestation 650 A.. | 1 0.64 18.47 Carestation 620 A2, Carestation 650 A.. | 1 0.64 19.11 Central Venous Catheter Set Heparin C.. | 1 0.64 19.75 Central Venous Catheter Set Triple Lu.. | 1 0.64 20.38 Central Venous Catheter Tray Triple L.. | 1 0.64 21.02 Central Venous Tray Triple Lumen Poly.. | 1 0.64 21.66 Contiplex Nerve Block Tray. Product C.. | 1 0.64 22.29 Custom Made Tracheostomy Device Th.. | 1 0.64 22.93 Customer Epidural Anesthesia Tray. Pr.. | 1 0.64 23.57 ELAN 4 Blade: ELAN 4 1-RING PIN CUTTE.. | 1 0.64 24.20 ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR.. | 1 0.64 24.84 ELAN 4 Drill: ELAN 4 1-RING TWIST DRI.. | 1 0.64 25.48 EMS products from Graham Medical, Snu.. | 1 0.64 26.11 Exactech GPS Total Shoulder Applicati.. | 1 0.64 26.75 Famciclovir Tablets, 500 mg, 30-count.. | 1 0.64 27.39 Fluoxetine Tablets USP, 10 mg, 30-cou.. | 1 0.64 28.03 Frozen Sliced (blanched) Squash packe.. | 1 0.64 28.66 G7 DUAL MOBILITY LINER 44MM F Prod.. | 1 0.64 29.30 HCG 5,000 IU/mL + Methylcobalamin 500.. | 1 0.64 29.94 Hemotherm¿ Dual Reservoir Cooler/Heat.. | 1 0.64 30.57 Hologic Panther(R) Fusion(TM), Catalo.. | 1 0.64 31.21 Human Cornea | 1 0.64 31.85 Independent Care System Corinz, Conta.. | 1 0.64 32.48 Ingenuity TF PET/CT (model 882442) ru.. | 1 0.64 33.12 JS Series SterilContainer S2 System | 1 0.64 33.76 Klonopin (clonazepam) 0.5 mg Tablets,.. | 1 0.64 34.39 Larabar Chocolate Chip Cookie Dough, .. | 1 0.64 35.03 Limbrel (flavocoxid 250 mg) capsules,.. | 1 0.64 35.67 Limbrel (flavocoxid 500 mg) capsules,.. | 1 0.64 36.31 Limbrel250 (flavocoxid and citrated z.. | 1 0.64 36.94 Limbrel500 (flavocoxid and citrated z.. | 1 0.64 37.58 Live Better Drug Free Black Elderberr.. | 1 0.64 38.22 Lyophilized Chemistry Calibrator Leve.. | 1 0.64 38.85 Marshelder, True (Rough) | 1 0.64 39.49 Medtronic ANGLED DRILL, REF 6630902, .. | 1 0.64 40.13 Model #: CG8900, Medtronic Clip Gun S.. | 1 0.64 40.76 Multi-Unit Abutment Angled, 17¿, 4mm .. | 1 0.64 41.40 NORCO (Hydrocodone Bitartrate and Ace.. | 1 0.64 42.04 NS357R Vega PS Tibia Trial/Preparatio.. | 1 0.64 42.68 Norian Drillable Inject | 2 1.27 43.95 Nose to Toes Skin Antisepsis, Oral Cl.. | 1 0.64 44.59 Oral Cleaning and Suctioning System q.. | 1 0.64 45.22 Oral Cleansing & Suctioning System q2.. | 1 0.64 45.86 Oral Cleansing & Suctioning System q4.. | 1 0.64 46.50 Oral Cleansing & Suctioning System wi.. | 1 0.64 47.13 Oral Cleansing & Suctioning System wi.. | 1 0.64 47.77 Oral Cleansing & Suctioning System wi.. | 1 0.64 48.41 PENCAN Spinal Anesthesia Tray. Produc.. | 1 0.64 49.04 Pain Management Tray. Product Catalog.. | 1 0.64 49.68 Pencan Spinal Needle Tray. Product Ca.. | 1 0.64 50.32 Perifix Continuous Epidural Anesthesi.. | 1 0.64 50.96 Perifix Epidural AnesthesiaTray. Prod.. | 1 0.64 51.59 Perifix FX Epidural Anesthesia Tray. .. | 1 0.64 52.23 Perifix Single Dose Epidural Anesthes.. | 1 0.64 52.87 Persona Partial Knee System Produc.. | 1 0.64 53.50 Purely Yours Breast Pump. Model 1707.. | 1 0.64 54.14 Q CARE q2 Oral Cleansing & Suctioning.. | 1 0.64 54.78 Q CARE q2 Oral Cleansing & Suctioning.. | 1 0.64 55.41 Q CARE q4 Oral Cleaning & Suctioning .. | 1 0.64 56.05 Q CARE q4 Oral Cleansing & Suctioning.. | 1 0.64 56.69 Q CARE q4 Oral Cleansing & Suctioning.. | 1 0.64 57.32 Q Care Continue Care for the non-vent.. | 1 0.64 57.96 Q Care Continue Care for the non-vent.. | 1 0.64 58.60 Q Care Oral Cleansing & Suctioning Sy.. | 1 0.64 59.24 Q Care RX Oral Cleansing & Suctioning.. | 1 0.64 59.87 Q Care RX Petite Oral Cleansing & Suc.. | 1 0.64 60.51 Q Care RX Petite Oral Cleansing & Suc.. | 1 0.64 61.15 Q Care, Oral Cleansing & Suctioning S.. | 1 0.64 61.78 Q.CARE Oral Cleansing & Suctioning Sy.. | 1 0.64 62.42 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 63.06 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 63.69 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 64.33 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 64.97 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 65.61 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 66.24 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 66.88 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 67.52 Q.Care Oral Cleansing & Suctioning Sy.. | 1 0.64 68.15 Q.Care Petite Size Oral Cleansing & S.. | 1 0.64 68.79 Q.Care Petite Size Oral Cleansing & S.. | 1 0.64 69.43 Q.Care, Oral Cleansing & Suctioning S.. | 1 0.64 70.06 Q.CareOral Cleansing & Suctioning Sys.. | 1 0.64 70.70 QCare Oral Cleansing and Suctioning S.. | 1 0.64 71.34 QCare RX Q2 Oral Cleansing & Suctioni.. | 1 0.64 71.97 QCare Rx Oral Cleansing and Suctionin.. | 1 0.64 72.61 Radial Artery Catheterization Set, 1).. | 1 0.64 73.25 Response 5.5/6.0 Spine System 7.0mm.. | 1 0.64 73.89 STAR WARS TIN WITH CARAMEL POPCORN NE.. | 1 0.64 74.52 Senna Laxative (sennosides) tablets, .. | 1 0.64 75.16 Skin antisepsis and oral cleansing. C.. | 1 0.64 75.80 Spectrum Central Venous Catheter Tray.. | 1 0.64 76.43 Spinal & Epidural Anesthesia Tray. Pr.. | 1 0.64 77.07 Synvisc-One ¿ (hylan G-F 20), 6mL del.. | 1 0.64 77.71 The ELAN 4 Air System is intended for.. | 1 0.64 78.34 Toothette Oral Care Single Use Syste.. | 1 0.64 78.98 Toothette Oral Care Antiseptic Oral R.. | 1 0.64 79.62 Toothette Oral Care Daily Oral Cleans.. | 1 0.64 80.25 Toothette Oral Care Perox-A- Mint sol.. | 1 0.64 80.89 Toothette Oral Care Perox-A-Mint Solu.. | 1 0.64 81.53 Toothette Oral Care Q Care & Suctioni.. | 1 0.64 82.17 Toothette Oral Care Short Term Oral C.. | 1 0.64 82.80 Toothette Oral Care Short Term Oral S.. | 1 0.64 83.44 Toothette Oral Care Short Term Oral S.. | 1 0.64 84.08 Toothette Oral Care Short Term Oral S.. | 1 0.64 84.71 Toothette Oral Care Short-Term Oral S.. | 1 0.64 85.35 Toothette Oral Care Single Use System.. | 1 0.64 85.99 Toothette Oral Care Single Use System.. | 1 0.64 86.62 Toothette Oral Care Suction Swab Syst.. | 1 0.64 87.26 Toothette Oral Care Suction Swab Syst.. | 1 0.64 87.90 Toothette Oral Care Suction Swab Syst.. | 1 0.64 88.54 Toothette Oral Care Suction Swabs wit.. | 1 0.64 89.17 Toothette Oral Care Suction Swabs wit.. | 1 0.64 89.81 Toothette Oral Care Suction Toothbrus.. | 1 0.64 90.45 Toothette Oral Care Suction Toothbrus.. | 1 0.64 91.08 Toothette Oral Care Suction Toothbrus.. | 1 0.64 91.72 Toothette Oral Care Suction Toothbrus.. | 1 0.64 92.36 Toothette Oral Care Suction Toothbrus.. | 1 0.64 92.99 Toothette Oral Care Suction Toothbrus.. | 1 0.64 93.63 Toothette Short Term Oral Swab System.. | 1 0.64 94.27 Toothette Suction Toothbrush with Per.. | 1 0.64 94.90 Total Knee Replacement , Catalog/Mode.. | 1 0.64 95.54 Vado Bi-Directional Steerable Sheath .. | 1 0.64 96.18 Vado Steerable Sheath 8.8F, REF SS8FM.. | 1 0.64 96.82 Video Cystoscope models ECY-1570 and .. | 1 0.64 97.45 WALNUT CREEK FOODS Caramel Popcorn NE.. | 1 0.64 98.09 Weis Weis Markets, Inc., Sunbury, PA .. | 1 0.64 98.73 Xpert CT/NG Catalog GXCT/NG-120 Batch.. | 1 0.64 99.36 Zero for Him 150 count | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for productquantity variable in enfrep20180221 dataset : Product Quantity | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 3 1.91 1.91 1 | 1 0.64 2.55 1 bottle | 1 0.64 3.18 1 human cornea | 1 0.64 3.82 1,137 bottles | 1 0.64 4.46 1,157,095 bottles | 1 0.64 5.10 1,275 units total | 1 0.64 5.73 10,100 bottles | 1 0.64 6.37 10/1 mL vials | 1 0.64 7.01 103 units | 1 0.64 7.64 10505 Cases | 1 0.64 8.28 10984 | 1 0.64 8.92 11 devices | 1 0.64 9.55 11,920 units | 1 0.64 10.19 11194 CASES | 1 0.64 10.83 1160 bags (total for all products) | 2 1.27 12.10 1160 bags(total for all products) | 1 0.64 12.74 1182 kits | 1 0.64 13.38 12,380 units | 1 0.64 14.01 120 units | 1 0.64 14.65 1273 Cases | 1 0.64 15.29 13 Units | 1 0.64 15.92 13,041 cases | 1 0.64 16.56 13,536 bottles | 1 0.64 17.20 135,277 bottles | 1 0.64 17.83 1355 units | 1 0.64 18.47 14,753 cases | 1 0.64 19.11 147 cases | 1 0.64 19.75 15,644 cases | 1 0.64 20.38 150 Cases | 1 0.64 21.02 153 cases, 30 units in each case | 1 0.64 21.66 160,489 bottles | 1 0.64 22.29 16639 Cases | 1 0.64 22.93 167 Units | 1 0.64 23.57 1680 KITS | 1 0.64 24.20 17554 bottles | 1 0.64 24.84 180,900 lbs | 1 0.64 25.48 1863 | 1 0.64 26.11 19 | 1 0.64 26.75 191/100 mL bottles and 21/250 mL bott.. | 1 0.64 27.39 2 units | 2 1.27 28.66 2,194 cases | 1 0.64 29.30 2,199 cases | 1 0.64 29.94 2,400 bottles | 1 0.64 30.57 2,429 cases | 1 0.64 31.21 2,548 cases | 1 0.64 31.85 2,938 cases | 1 0.64 32.48 20 Cases | 1 0.64 33.12 20 units | 1 0.64 33.76 2017 Cases | 1 0.64 34.39 207 worldwide (13 distributed in US) | 1 0.64 35.03 21 Units | 1 0.64 35.67 239 units | 1 0.64 36.31 24 | 2 1.27 37.58 24 units | 1 0.64 38.22 2408 Cases | 1 0.64 38.85 2424 Cases | 1 0.64 39.49 2468 Cases | 1 0.64 40.13 2480 units | 1 0.64 40.76 25 | 1 0.64 41.40 25 Cases | 2 1.27 42.68 25,409 cases | 1 0.64 43.31 261 sheaths | 1 0.64 43.95 2660 units | 1 0.64 44.59 2691 total | 2 1.27 45.86 27,432.8 devices | 1 0.64 46.50 270 cartons | 1 0.64 47.13 28 devices | 1 0.64 47.77 292 units | 1 0.64 48.41 2970 Cases | 1 0.64 49.04 3,192 bottles | 1 0.64 49.68 3,327 units total | 1 0.64 50.32 3,586 kits (49,400 units) | 1 0.64 50.96 30 vials | 1 0.64 51.59 300 units | 1 0.64 52.23 304 | 1 0.64 52.87 324 cs/9/15 oz packages | 1 0.64 53.50 329 tins | 1 0.64 54.14 330 | 1 0.64 54.78 33108 cases of 5 units | 1 0.64 55.41 343 units | 1 0.64 56.05 36 cases of 5 units | 1 0.64 56.69 373/100 mL bottles and 51/250 mL bott.. | 1 0.64 57.32 38,792 cases | 1 0.64 57.96 3928 Cases | 1 0.64 58.60 4 units | 1 0.64 59.24 4,006 bottles | 1 0.64 59.87 4,061 cases | 1 0.64 60.51 41 devices | 1 0.64 61.15 42,628 cases | 1 0.64 61.78 4255 Cases | 1 0.64 62.42 4298 Cases | 1 0.64 63.06 460 units | 1 0.64 63.69 4650 Cases | 1 0.64 64.33 48,003 cases | 1 0.64 64.97 480 Cases | 1 0.64 65.61 5 units | 1 0.64 66.24 5 vials | 1 0.64 66.88 5,148 devices | 2 1.27 68.15 5,217 cases | 1 0.64 68.79 5,579 cases | 1 0.64 69.43 50 | 1 0.64 70.06 5085 Cases | 1 0.64 70.70 5138 Cases | 1 0.64 71.34 5303 Cases | 1 0.64 71.97 6,200 cases | 1 0.64 72.61 60 Cases | 2 1.27 73.89 6130 Cases | 1 0.64 74.52 62 vials | 1 0.64 75.16 6211 | 2 1.27 76.43 633 Cases | 1 0.64 77.07 637 cases | 1 0.64 77.71 640 cases | 1 0.64 78.34 6461 Cases | 1 0.64 78.98 6472 Cases | 1 0.64 79.62 67,040 unique users of version 2.1.0 | 1 0.64 80.25 672 Cases | 1 0.64 80.89 6720 units | 1 0.64 81.53 6726 Cases | 1 0.64 82.17 7,826 bottles | 1 0.64 82.80 700 | 1 0.64 83.44 700 units | 1 0.64 84.08 7490 PACKETS | 1 0.64 84.71 75 | 1 0.64 85.35 8 | 1 0.64 85.99 8 bottles | 1 0.64 86.62 8,231 devices total | 2 1.27 87.90 8,436 bottles | 1 0.64 88.54 82072 Cases | 1 0.64 89.17 835 cases | 1 0.64 89.81 8466 Cases | 1 0.64 90.45 849 cases | 1 0.64 91.08 85 | 1 0.64 91.72 852 cases | 1 0.64 92.36 8630 units | 1 0.64 92.99 879 cases | 1 0.64 93.63 887 cases | 1 0.64 94.27 9,006 cases | 1 0.64 94.90 9,110 cases | 1 0.64 95.54 9,800 units | 1 0.64 96.18 94 cases | 1 0.64 96.82 945 cases | 1 0.64 97.45 966 cases | 1 0.64 98.09 99 sheaths | 1 0.64 98.73 approx. 150 units | 1 0.64 99.36 unknown | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for reasonforrecall variable in enfrep20180221 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- controlled drug classification indic.. | 1 0.64 0.64 on the Acquisition Workflow window d.. | 1 0.64 1.27 on their label. | 1 0.64 1.91 Abutments are unable to accept the fi.. | 1 0.64 2.55 Adesign change to 3M(TM) Bair Hugger(.. | 2 1.27 3.82 B. Braun Medical Inc. (BBMI) initiate.. | 8 5.10 8.92 B. Braun Medical Inc. (BBMI) initiate.. | 2 1.27 10.19 BMD has identified that some lots of .. | 1 0.64 10.83 CGMP Deviations: not manufactured acc.. | 1 0.64 11.46 Central venous catheters may not fit .. | 5 3.18 14.65 Cepheid has received reports that som.. | 1 0.64 15.29 Certain iOS and Android App versions .. | 1 0.64 15.92 Contamination with Methylbacterium th.. | 1 0.64 16.56 Cross Contamination With Other Produc.. | 64 40.76 57.32 Cut resistant surgical glove liners l.. | 1 0.64 57.96 Due to FDA's safety communication rel.. | 1 0.64 58.60 ELAN 4 burr/blade accessories were ma.. | 3 1.91 60.51 Failed Dissolution Specifications: Su.. | 1 0.64 61.15 Failed impurities/ degradation specif.. | 1 0.64 61.78 Finished good kits may contain incorr.. | 2 1.27 63.06 Firm is recalling multiple products f.. | 3 1.91 64.97 Gas developing in sealed bottle. | 1 0.64 65.61 Hibiscus Lavender Syrup is recalled b.. | 1 0.64 66.24 Human cornea, not tested adequately a.. | 1 0.64 66.88 Implant kit mislabeled | 1 0.64 67.52 Incorrect device in the package. A pa.. | 2 1.27 68.79 Label does not list sub-ingredients f.. | 1 0.64 69.43 Labeling: Label Mix-Up: Customer comp.. | 1 0.64 70.06 Labeling: Not Elsewhere Classified: S.. | 1 0.64 70.70 Lack of sterility assurance. | 1 0.64 71.34 Larabar Chocolate Chip Cookie Dough, .. | 1 0.64 71.97 Lemon Ginger Syrup is recalled becaus.. | 1 0.64 72.61 Licensed Allergenic Extracts, with a .. | 2 1.27 73.89 Marketed Without An Approved NDA/ANDA.. | 4 2.55 76.43 Marketed without an Approved NDA/ANDA.. | 1 0.64 77.07 Medtronic has discovered the product .. | 1 0.64 77.71 Medtronic is initiating a voluntary r.. | 1 0.64 78.34 Needle supplier indicated the presenc.. | 1 0.64 78.98 Possible incomplete seal between the .. | 2 1.27 80.25 Potential for the Persona Partial Kne.. | 1 0.64 80.89 Product may be contaminated with Salm.. | 2 1.27 82.17 Routine analysis by consignee found o.. | 1 0.64 82.80 Smiths Medical determined that a sing.. | 1 0.64 83.44 Sun Pharmaceutical is recalling Azela.. | 1 0.64 84.08 Temperature Abuse: Complaints of tabl.. | 1 0.64 84.71 The 7mm diameter uniaxial pedicle scr.. | 1 0.64 85.35 The ELAN 4 Air System was released to.. | 1 0.64 85.99 The JS Series SterilContainer S2 Syst.. | 1 0.64 86.62 The NS357R Vega PS Tibia Trial/Prepar.. | 1 0.64 87.26 The Panther or the Panther Fusion gla.. | 1 0.64 87.90 The affected AGC 2000 LP Patella prod.. | 2 1.27 89.17 The affected products are labeled and.. | 1 0.64 89.81 The contract supplier notified DePuy .. | 2 1.27 91.08 The firm information that the product.. | 1 0.64 91.72 The firm was notified by a customer t.. | 1 0.64 92.36 The locking mechanism and protective .. | 1 0.64 92.99 The possibility exists for the monito.. | 1 0.64 93.63 The secondary supplier provided mater.. | 1 0.64 94.27 The swab stick collection device prov.. | 1 0.64 94.90 The video cytoscopes lack 510(k) prem.. | 1 0.64 95.54 Torn sheath liner material was detect.. | 2 1.27 96.82 Two specific lots was incorrectly man.. | 1 0.64 97.45 Unpaired lots of AU lyophilized chemi.. | 1 0.64 98.09 Updated on-device label and 3 pages o.. | 2 1.27 99.36 Vix Bit may fracture during use. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for centerclassificationdate variable in enfrep20180221 dataset : Center | Classificat | ion Date | Freq. Percent Cum. ------------+----------------------------------- | 3 1.91 1.91 02/09/2018 | 90 57.32 59.24 02/12/2018 | 10 6.37 65.61 02/13/2018 | 15 9.55 75.16 02/14/2018 | 12 7.64 82.80 02/15/2018 | 24 15.29 98.09 02/16/2018 | 2 1.27 99.36 02/20/2018 | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for terminationdate variable in enfrep20180221 dataset : Termination | Date | Freq. Percent Cum. ------------+----------------------------------- | 152 96.82 96.82 02/13/2018 | 1 0.64 97.45 02/14/2018 | 3 1.91 99.36 02/20/2018 | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for codeinfo variable in enfrep20180221 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- #6600 TJ TORTILLA, Net Wt. 50 Lbs, Co.. | 1 0.64 0.64 000417 USE BY 062009 | 1 0.64 1.27 000917 USE BY 012019 | 1 0.64 1.91 0061480957. | 1 0.64 2.55 0061480990. 0061519897. 0061522568... | 1 0.64 3.18 0061481027. 0061517645. 0061523759... | 1 0.64 3.82 0061482555. 0061515153. 0061518685... | 1 0.64 4.46 0061482582. 0061509281. 0061523764... | 1 0.64 5.10 0061483775. 0061486469. 0061519983... | 1 0.64 5.73 0061522622. 0061537909. | 1 0.64 6.37 0061523813. 0061536453. | 1 0.64 7.01 0061525340. 0061535836. | 1 0.64 7.64 0061539146. 0061540984. | 1 0.64 8.28 336044; | 1 0.64 8.92 336106; | 1 0.64 9.55 Affected Lots: D80412, D84100, E00008.. | 1 0.64 10.19 All lots remaining within expiry. | 1 0.64 10.83 All lots within expiry. | 4 2.55 13.38 All lots within expiry. Lot # 732259.. | 1 0.64 14.01 All lots, Model Number: GP111R GP112.. | 1 0.64 14.65 All lots, Model Number: GP188R GP189.. | 1 0.64 15.29 All lots, Model Number: GP190R GP201.. | 1 0.64 15.92 Avid Medical Kit Lot 1235229 (expirat.. | 1 0.64 16.56 BESTBY 30SEPT2018 Packing Lot Code 76.. | 1 0.64 17.20 BROLITE PRODUCT #5015 SPONGE AND DOUG.. | 1 0.64 17.83 BROLITE PRODUCT #6109 BREAD FLAVOR R,.. | 1 0.64 18.47 Best by date: 4/30/2018 | 1 0.64 19.11 Best if Used By 01MAY2018 | 1 0.64 19.75 Catalog No. 531-15-08, Lot No. 752960.. | 1 0.64 20.38 CritiCore(R) Monitor Affected Serial .. | 1 0.64 21.02 ELAN 4 Air System ST0607 ELAN 4 Air.. | 1 0.64 21.66 GS025081 | 1 0.64 22.29 Ingenuity TF PET/CT (model 882442) S.. | 1 0.64 22.93 Item #110024464 Lot# 478340 | 1 0.64 23.57 Item No. 42539909100; Lot No. (UDI No.. | 1 0.64 24.20 Item No. 60400040400, Lot No. 6251054.. | 1 0.64 24.84 Item Number Lot Number Expiration D.. | 1 0.64 25.48 JKR7706A December 2018 JKR7705A Nove.. | 1 0.64 26.11 JS440 S2 1/1CONT.BOTTON PERFOR.H88MM .. | 1 0.64 26.75 KK170067; KK170070; K170071 | 1 0.64 27.39 Lot # 3141989, EXP 08/31/2019 | 1 0.64 28.03 Lot # 352300, Exp 01/19 | 1 0.64 28.66 Lot # 5072543 Exp Date 03/12/2021; UD.. | 1 0.64 29.30 Lot # 544821A, Exp 07/19 | 1 0.64 29.94 Lot # FMC17039, Exp 07/2019. | 1 0.64 30.57 Lot #'s: 16198721; 16198708; 16198702.. | 1 0.64 31.21 Lot #0559, exp. 10/9/2018, and Lot #0.. | 1 0.64 31.85 Lot #0594, exp. 1/19/2018, and Lot #0.. | 1 0.64 32.48 Lot #: 174096, Exp 05/31/19 | 1 0.64 33.12 Lot 7E058 and Lot 7E308 | 1 0.64 33.76 Lot H302839, Expiration Date 31Jan2026 | 1 0.64 34.39 Lot No. Item No. 60400040400, Lot No... | 1 0.64 35.03 Lot Number (Expiration date): 5901462.. | 1 0.64 35.67 Lot Number (Expiration date): 5918090.. | 1 0.64 36.31 Lot Number (Expiration date): 5919800.. | 1 0.64 36.94 Lot Number (Expiration date): 7693203.. | 1 0.64 37.58 Lot Number (Expiration date): NS59147.. | 1 0.64 38.22 Lot Number: 7RSL021 Expiration Date:.. | 1 0.64 38.85 Lot Numbers: FR10361 | 1 0.64 39.49 Lot Numbers: R10359, R10360, R10361,.. | 1 0.64 40.13 Lot Numbers: 1) 23F16H0859 & 2) 23F16.. | 1 0.64 40.76 Lot codes: 17871, 17971, 18071, and .. | 1 0.64 41.40 Lot numbers: 25718, 25719, 25725, and.. | 1 0.64 42.04 Lot# 1701-092 | 1 0.64 42.68 Lot#1710638B | 1 0.64 43.31 Lot/Batch Numbers: 13F16A0089, 13F1.. | 1 0.64 43.95 Lot/Batch Numbers: 23F17A0038, 23F1.. | 1 0.64 44.59 Lot: 01052018@46 Use By: 2/9/2018 | 1 0.64 45.22 Lot: 17JXIII, Exp. 12/31/2019 | 1 0.64 45.86 Lots # 6101K51 and 6101K61 | 1 0.64 46.50 Lots:52115, EXP 08/04/2017; 52284, 52.. | 1 0.64 47.13 Model No. 1012-9620-000, 1012-9650-00.. | 1 0.64 47.77 Model No. 1012-9620-000, 1012-9650-00.. | 1 0.64 48.41 Model No. 150802: Lot No. 305330 (UDI.. | 1 0.64 49.04 Model No. 150804: Lot No. 088080 ((01.. | 1 0.64 49.68 Model number: 00-1300-0740, Lot numbe.. | 1 0.64 50.32 Part No. 3L93709 and Lot No. 5291990 | 1 0.64 50.96 Part No. L20314 and Lot No. 5292130 | 1 0.64 51.59 Product Code: 6001-D; Lots: 52414, 53.. | 1 0.64 52.23 Product Code: 6001; Lots: 52267, EXP .. | 1 0.64 52.87 Product Code: 6002-D; Lots: 57942, EX.. | 1 0.64 53.50 Product Code: 6002; Lots: Product Cod.. | 1 0.64 54.14 Product Code: 6004; Lots: 61610, EXP .. | 1 0.64 54.78 Product Code: 6006; Lots: 54523,54629.. | 1 0.64 55.41 Product Code: 6012; Lots: 51502, EXP .. | 1 0.64 56.05 Product Code: 6013; Lots: 51361, EXP .. | 1 0.64 56.69 Product Code: 6060; Lots: 53057, EXP .. | 1 0.64 57.32 Product Code: 6065; Lots: 51450; EXP .. | 1 0.64 57.96 Product Code: 6100; Lots: 57856, 5829.. | 1 0.64 58.60 Product Code: 6113; Lots: 57874, EXP.. | 1 0.64 59.24 Product Code: 6115; Lots: 58483, EXP.. | 1 0.64 59.87 Product Code: 6122; Lots: 020387, EXP.. | 1 0.64 60.51 Product Code: 6173; Lots: 57899, EXP.. | 1 0.64 61.15 Product Code: 6306; Lots: 55203, 552.. | 1 0.64 61.78 Product Code: 6308; Lots: 55134, EXP.. | 1 0.64 62.42 Product Code: 6404; Lots: 58394, EXP.. | 1 0.64 63.06 Product Code: 6412; Lots: 58432, EXP.. | 1 0.64 63.69 Product Code: 6414; Lots: 57847, EXP .. | 1 0.64 64.33 Product Code: 6422; Lots: 57496, 5755.. | 1 0.64 64.97 Product Code: 6424; Lots: 57386, EXP .. | 1 0.64 65.61 Product Code: 6434; Lots: 58519, 5853.. | 1 0.64 66.24 Product Code: 6462; Lots: 55152, EXP .. | 1 0.64 66.88 Product Code: 6464; Lots: 55175 EXP 8.. | 1 0.64 67.52 Product Code: 6502; Lots: 57627, EXP .. | 1 0.64 68.15 Product Code: 6504; Lots: 58174, EXP .. | 1 0.64 68.79 Product Code: 6512; Lots: 51381, EXP .. | 1 0.64 69.43 Product Code: 6513; Lots: 51175, 5122.. | 1 0.64 70.06 Product Code: 6550; Lots: 51590, EXP .. | 1 0.64 70.70 Product Code: 6552; Lots: 52573, 5292.. | 1 0.64 71.34 Product Code: 6570; Lots: 51571, EX.. | 1 0.64 71.97 Product Code: 6571; Lots: 52384, EXP .. | 1 0.64 72.61 Product Code: 6572; Lots: 52349, 5236.. | 1 0.64 73.25 Product Code: 6592-S; Lots: 62154 EXP.. | 1 0.64 73.89 Product Code: 6592; Lots: 54071, EXP .. | 1 0.64 74.52 Product Code: 6594-S; Lots:52348, EXP.. | 1 0.64 75.16 Product Code: 6594; Lots: 53018, 5382.. | 1 0.64 75.80 Product Code: 6602; Lots: 52005, EXP .. | 1 0.64 76.43 Product Code: 6613; Lots: 51330, EXP .. | 1 0.64 77.07 Product Code: 6671; Lots: 51716, EXP .. | 1 0.64 77.71 Product Code: 6673; Lots: 57938, EXP .. | 1 0.64 78.34 Product Code: 6704; Lots: 58121, EXP .. | 1 0.64 78.98 Product Code: 6714; Lots: 57979, EXP .. | 1 0.64 79.62 Product Code: 6802; Lots: 57509, EXP .. | 1 0.64 80.25 Product Code: 6804; Lots: 57567, EXP .. | 1 0.64 80.89 Product Code: 6808; Lots: 57592, EXP .. | 1 0.64 81.53 Product Code: 6904; Lots: 52850, 5328.. | 1 0.64 82.17 Product Code: 6912-S; Lots: 54675, EX.. | 1 0.64 82.80 Product Code: 6912; Lots: 52736, 5280.. | 1 0.64 83.44 Product Code: 6914-S; Lots: 52435, EX.. | 1 0.64 84.08 Product Code: 6914; Lots: 52775, 5287.. | 1 0.64 84.71 Product Code: 6922-B; Lots: 53070, EX.. | 1 0.64 85.35 Product Code: 6922; Lots: 51408, EXP .. | 1 0.64 85.99 Product Code: 6924; Lots: 51601, EXP .. | 1 0.64 86.62 Product Code: 6962; Lots: 55604, 5561.. | 1 0.64 87.26 Product Code: 6964; Lots: 56718, EXP .. | 1 0.64 87.90 Product Code: 6974-S; Lots: 58317, EX.. | 1 0.64 88.54 Product Code: 6974; Lots: 58322, 5864.. | 1 0.64 89.17 Product Code: 6994; Lots: 58092, EXP .. | 1 0.64 89.81 Product Code: 9002; Lots: 52886, EXP .. | 1 0.64 90.45 Product Code: 9009; Lots: 60354, EXP .. | 1 0.64 91.08 Product Code: 9010; Lots: 60298, 6035.. | 1 0.64 91.72 Product Number: 07.704.003S Lot Numb.. | 1 0.64 92.36 Product Number: 07.704.010S Lot Numb.. | 1 0.64 92.99 REF - 45324K Lot Number - 33006 Exp.. | 1 0.64 93.63 SELL BY RANGE 8/12/2009 02/16/2018 | 1 0.64 94.27 Serial # 82044; 82105; 82070; 82054; .. | 1 0.64 94.90 Serial Numbers: 2090002307, 209000230.. | 1 0.64 95.54 Serial number: J110097 J110101 G110.. | 1 0.64 96.18 Serial numbers: 0398482 & 0399917 Ex.. | 1 0.64 96.82 Software Versions: 1.2.0, 1.2.2, 1.2... | 1 0.64 97.45 The product is located in the Vega Ti.. | 1 0.64 98.09 UDI: 00643169363502, Lot Number EM17.. | 1 0.64 98.73 W412317012152; | 1 0.64 99.36 none | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo1 variable in enfrep20180221 dataset : More Code Info 1 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 155 98.73 98.73 070006, 401505070007, 401505070008, 4.. | 1 0.64 99.36 616160009WA SM616330001WA SM6164400.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo2 variable in enfrep20180221 dataset : More Code Info 2 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 155 98.73 98.73 03220010 401603220011 401603220012 .. | 1 0.64 99.36 180010MA SM716200020MA SM716200021M.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo3 variable in enfrep20180221 dataset : More Code Info 3 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 155 98.73 98.73 010084068210398521SM617040015WA1117.. | 1 0.64 99.36 401612120019 401612120020 4016121.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo4 variable in enfrep20180221 dataset : More Code Info 4 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 156 99.36 99.36 98521SM617060029MA11170207 010084068.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo5 variable in enfrep20180221 dataset : More Code Info 5 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 156 99.36 99.36 10394721SM716510033WA11161222 010084.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo6 variable in enfrep20180221 dataset : More Code Info 6 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 156 99.36 99.36 68210398521SM617260020MA11170629 010.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo7 variable in enfrep20180221 dataset : More Code Info 7 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 156 99.36 99.36 084068210398521SM617340012WA11170823 .. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for morecodeinfo8 variable in enfrep20180221 dataset : More Code Info 8 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 156 99.36 99.36 010084068210398521SM617170043MA111704.. | 1 0.64 100.00 ----------------------------------------+----------------------------------- Total | 157 100.00 Frequencies for recallinitiationdate variable in enfrep20180221 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 15jul2016 | 1 0.64 0.64 20jan2017 | 1 0.64 1.27 08jun2017 | 1 0.64 1.91 20jun2017 | 1 0.64 2.55 21jun2017 | 10 6.37 8.92 03jul2017 | 1 0.64 9.55 10jul2017 | 2 1.27 10.83 11jul2017 | 1 0.64 11.46 12jul2017 | 2 1.27 12.74 13jul2017 | 1 0.64 13.38 21jul2017 | 1 0.64 14.01 24jul2017 | 1 0.64 14.65 25jul2017 | 2 1.27 15.92 27jul2017 | 2 1.27 17.20 31jul2017 | 5 3.18 20.38 03aug2017 | 1 0.64 21.02 10aug2017 | 3 1.91 22.93 22aug2017 | 65 41.40 64.33 24aug2017 | 1 0.64 64.97 25aug2017 | 3 1.91 66.88 28aug2017 | 1 0.64 67.52 01sep2017 | 1 0.64 68.15 05sep2017 | 3 1.91 70.06 08sep2017 | 1 0.64 70.70 11sep2017 | 1 0.64 71.34 09oct2017 | 1 0.64 71.97 11oct2017 | 2 1.27 73.25 10nov2017 | 1 0.64 73.89 27nov2017 | 1 0.64 74.52 30nov2017 | 1 0.64 75.16 11dec2017 | 2 1.27 76.43 14dec2017 | 2 1.27 77.71 19dec2017 | 1 0.64 78.34 20dec2017 | 1 0.64 78.98 22dec2017 | 2 1.27 80.25 27dec2017 | 1 0.64 80.89 12jan2018 | 4 2.55 83.44 17jan2018 | 1 0.64 84.08 19jan2018 | 1 0.64 84.71 20jan2018 | 3 1.91 86.62 23jan2018 | 2 1.27 87.90 25jan2018 | 2 1.27 89.17 26jan2018 | 5 3.18 92.36 29jan2018 | 3 1.91 94.27 01feb2018 | 2 1.27 95.54 02feb2018 | 2 1.27 96.82 05feb2018 | 3 1.91 98.73 06feb2018 | 1 0.64 99.36 07feb2018 | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for recallinitiationdatestr variable in enfrep20180221 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 01/12/2018 | 4 2.55 2.55 01/17/2018 | 1 0.64 3.18 01/19/2018 | 1 0.64 3.82 01/20/2017 | 1 0.64 4.46 01/20/2018 | 3 1.91 6.37 01/23/2018 | 2 1.27 7.64 01/25/2018 | 2 1.27 8.92 01/26/2018 | 5 3.18 12.10 01/29/2018 | 3 1.91 14.01 02/01/2018 | 2 1.27 15.29 02/02/2018 | 2 1.27 16.56 02/05/2018 | 3 1.91 18.47 02/06/2018 | 1 0.64 19.11 02/07/2018 | 1 0.64 19.75 06/08/2017 | 1 0.64 20.38 06/20/2017 | 1 0.64 21.02 06/21/2017 | 10 6.37 27.39 07/03/2017 | 1 0.64 28.03 07/10/2017 | 2 1.27 29.30 07/11/2017 | 1 0.64 29.94 07/12/2017 | 2 1.27 31.21 07/13/2017 | 1 0.64 31.85 07/15/2016 | 1 0.64 32.48 07/21/2017 | 1 0.64 33.12 07/24/2017 | 1 0.64 33.76 07/25/2017 | 2 1.27 35.03 07/27/2017 | 2 1.27 36.31 07/31/2017 | 5 3.18 39.49 08/03/2017 | 1 0.64 40.13 08/10/2017 | 3 1.91 42.04 08/22/2017 | 65 41.40 83.44 08/24/2017 | 1 0.64 84.08 08/25/2017 | 3 1.91 85.99 08/28/2017 | 1 0.64 86.62 09/01/2017 | 1 0.64 87.26 09/05/2017 | 3 1.91 89.17 09/08/2017 | 1 0.64 89.81 09/11/2017 | 1 0.64 90.45 10/09/2017 | 1 0.64 91.08 10/11/2017 | 2 1.27 92.36 11/10/2017 | 1 0.64 92.99 11/27/2017 | 1 0.64 93.63 11/30/2017 | 1 0.64 94.27 12/11/2017 | 2 1.27 95.54 12/14/2017 | 2 1.27 96.82 12/19/2017 | 1 0.64 97.45 12/20/2017 | 1 0.64 98.09 12/22/2017 | 2 1.27 99.36 12/27/2017 | 1 0.64 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for reportdate variable in enfrep20180221 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 21feb2018 | 157 100.00 100.00 ------------+----------------------------------- Total | 157 100.00 Frequencies for reportdatestr variable in enfrep20180221 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 02/21/2018 | 157 100.00 100.00 ------------+----------------------------------- Total | 157 100.00 by Jean Roth , jroth@nber.org , 22 Feb 2018