Recalling Firm
Philips Electronics North America Corporation
Blood Systems, Inc. dba United Blood Services Texas
Lifesouth Community Blood Centers - Montgomery Region
American Natl Red Cross Mid Atlantic Region
Transplant Services Center UT Southwestern Medical Center
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
NY (via 3 retail stores) and directly to 26 individual consumers (CT, FL, HI, NJ, PA, OH, MA, District of Columbia, VT & PR)
CA, PA, CO, IL, WI, MA, TX, MD, MI, MN, UT
This product was shipped to IL, OK, FL, WI, MI, CA, MD, AR and CO. The firm did not ship any product to foreign consignees.
Distribution in US (MI, NC, OH, NC, VA), and CANADA
Sold to customers in Jamaica and Florida
Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & DC.
Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
Product was distributed in the following states: AR, CT, MI, NC, OH, PA, TX, and VA. Product was distributed to one Canadian firm. No products were distributed to government accounts.
Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.
Worldwide Distribution - US Distribution and to the countries of : Argentina, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, Norway, Qatar, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom and Vietnam.
Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.
WI , IL, CA, WY, GA , MO, OK , IN , OH, PA, LA , NC, FL , TX , NY, MN.
Worldwide Distribution - US including CA and Internationally to Karachi, Spain, and Taiwan.
Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSALAM, BULGARIA,CAMBODIA,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, CROATIA (local name: Hrvatska),CYPRUS,CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC,ECUADOR,EGYPT,EL SALVADOR, ESTONIA, ETHIOPIA,FINLAND,FRANCE,GABON,GERMANY,GHANA,GREECE, GUADELOUPE, HONG KONG,HUNGARY,ICELAND,INDIA, INDONESIA,IRAN (ISLAMIC REPUBLIC OF),IRAQ,IRELAND,ISRAEL,ITALY,JAPAN, JORDAN, KAZAKHSTAN, KENYA,KOREA, REPUBLIC OF,KUWAIT,LAOS,LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA,LITHUANIA,LUXEMBOURG, MACAU, MACEDONIA,MALAYSIA,MALTA,MAURITIUS,MEXICO,MONGOLIA, MOROCCO, MOZAMBIQUE,MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES,NEW CALEDONIA,NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA,PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL,QATAR,REUNION,ROMANIA,RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA,SOUTH AFRICA,SPAIN,SRI LANKA, SWEDEN,SWITZERLAND,TAIWAN, PROVINCE OF CHINA,TANZANIA, UNITED REPUBLIC OF,THAILAND,TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN,UGANDA,UKRAINE,UNITED ARAB EMIRATES,UNITED KINGDOM,UZBEKISTAN,VENEZUELA,VIET NAM,YEMEN.
Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Domestic: Illinois, Indiana, Kentucky, Maryland, Minnesota, Missouri, Michigan, New York, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia Foreign: None VA/DOD: None
Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Domestic: IL, IN, KY, MI, OH, WI Foreign: None VA/DOD: None
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
distributed in AK, CA, CT, FL, IL, IN, KS, MO, NV, NY, OR, TX, UT, VA, and WA.
Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, and Portugal.
Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Worldwide distribution. US states: IA, IL, MI, NY, PA, and WI. Country: Jordan. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
Product was distributed to Ontario, Canada.
Nationwide Distribution to PA, TX, FL, AZ, IN, OH
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.
Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.
Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK..

Product Description
Baidyanath brand Arogyavardhini Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Rajahpravartini Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Sarivadi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Brahmi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Saptamrit Lauh, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Marichyadi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Chitrakadi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Agnitundi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Shankh Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Baidyanath brand Gaisantak Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Sunrise Brand Marinated Silver/White Croaker - 30 x 14oz, Item No. C0081, UPC 5 08 54336-50081 0
Sunrise Brand Marinated River Barb - 60 x 10 oz, Item No. C0140, UPC 2 08 54336-20140 2
Sunrise Brand Dehydrated Anchovy size 2/3cm - 1 x 22 lb, Item No. C0160, UPC 5 08 54336-50161 9
Sunrise Brand Dehydrated Anchovy size 3/5cm - 100 x 3.5oz, Item No. C0161, UPC 2 08 54336-20161 9
Sunrise Brand Marinated Climbing Perch - 30 x 16 oz, Item No. C0133, UPC 2 08 54336-20130 4
Sunrise Brand Dehydrated Big-Eye Herrings - 1 x 3.3 lb, Item No. C0201, UPC 5 08 54336-50201 2
Garlic Cheese Curds, unlabeled, Manufactured for repack and relabel cheeses.
Luqman Cheese, Jalapeno Jack, Net Wt. 8 oz. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
Dutchland Homestead, Gouda, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Colby cheeses various, unlabeled, Manufactured for repack and relabel cheeses.
Gouda, unlabeled, Manufactured for repack and relabel cheeses.
Dutchland Homestead, Colby Jack Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Luqman Cheese, Sharp Cheddar, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
Luqman Cheese, Buffalo Colby, Net Wt. 8 oz. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Buffalo Colby Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Luqman Cheese, Monterey Jack, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Monterey Jack Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Luqman Cheese, Yellow Colby Buffalo, Net Weight 8 oz., Dist by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Mineiro, unlabeled, Manufactured for repack and relabel cheeses.
Dutchland Homestead Farmer's Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Dutchland Homestead, American Cheese, Net Weight 8 oz.., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055;
Cheddar, all varieties unlabeled for repacking and relabeling.
Luqman Cheese, Yellow Colby, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
Dutchland Homestead, Cheddar Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Udder Delight, unlabeled, Manufactured for repack and relabel cheeses.
Monterey Jack various, unlabeled, Manufactured for repack and relabel cheeses.
Luqman Cheese Harvarti, Net Wt. 8 oz., Distributed by Cumberland Valley Creamery; Mechanicsburg, PA; OR Dutchland Homestead Harvarti, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Havarti Caraway, unlabeled, Manufactured for repack and relabel cheeses.
Luqman Cheese, Yellow Cheddar, Net Wt. 8 oz.,. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
Luqman Cheese, Colby Tomato Basil, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Colby Cheese Tomato Basil, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Chevre unlabeled, Manufactured for repacking and relabeling.
Luqman Cheese, White Cheddar, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
Feta, unlabeled, Manufactured for repack and relabel cheeses.
Dutchland Homestead Mozzarella, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Luqman Cheese, Yellow Colby Buffalo Ranch, Net Weight 8 oz., Dist by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
Farmer's Cheese, unlabeled, manufactured for repacking and relabeling
Luqman Cheese, White Colby, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
Sammy's Milk (Baby Food), Net Wt. 12.84 oz (364 g), 6 containers per case
Gourmet Kitchen Gourmet/Stuffed/French Toast with Strawberries & Mascarpone 20 PCS 1238 Corlies Avenue Neptune, NJ 07753 gourmetkitcheninc.com
Oriental Jamaican Hot Curry Powder, 50 lb bulk. Manufactured by Oriental Packing Co.
Ocho-Rios Jamaican Nice Hot Curry Powder, 4 oz. Manufactured by Oriental Packing Co.
Ocho-Rios Mild Curry Powder, 5 lb. Manufactured by Oriental Packing Co.
Ocho-Rios Jamaican Nice Mild Curry Powder, 4 oz. Manufactured by Oriental Packing Co.
Buffalo Blue Kettle Cooked Potato Chips 8 oz (227g)
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa
Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU
Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU
Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills
Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa
Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn
Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills
Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa
Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn
Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU
Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU
Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills
Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa
Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa
Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills
Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa
Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa
Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn
Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn
Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa
Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU
Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills
Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU
Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU
Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU
Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa
Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU
Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU
Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa
Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills
Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU
Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
Taco 6 White NGMO Corn Masa Flour 50 lb bags
Tortilla Chip 2 White Corn Masa Flour 50 lb bags
Tortilla Chip #8 Especial White NGMO Corn Masa Flour 50 lb bags
Truco 1 50/50 Corn Masa Flour 50 lb bags & totes
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709
Ruth's Old Fashion Pimento Spread, 16oz. (UPC 74952-15005), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
Ruth's Jalapeno Pimento Spread, 12 oz. (UPC 74952-12014), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
Ruth's Lite Pimento Spread, 12 oz. (UPC 74952-12000), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
Ruth's Original Pimento Spread 7oz (UPC 74952-0005), 12oz (UPC 74952-12023) and 24oz (74952-24023), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
Ruth's Cream Cheese w/Pineapple-Pecans, 12 oz. (UPC 74952-12008), Packed By: B & H Foods, 181 Saluda ST, Chester, SC 29706, packed in plastic containers.
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Plasma Frozen within 24 hours After Phlebotomy
Apheresis Red Blood Cells, Leukocytes Reduced
Dutchmark, Pasteurized Processed Smoked Gouda Cheese. Product case Label: 989922 Dutchmark, Net Wt 24.00.
Great Midwest Applewood Smoked Gouda Cheese, approximately 6 lbs, keep refrigerated
Blood and Blood Products for Reprocessing
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
La Fe Papa Criollas Yellow Potato Net Wt. 14 oz. Distributed: by La Fe Foods Moonachne, NJ 07074 UPC
KEEP REFRIGERATED SWEET GREEN Juice 5 Gal
KEEP REFIGERATED, DEEP BEET Blend 5 Gal, Ripe Liquid Produce
IMMUNITY SHOT 2 fl.oz., UPC: 859168006184
Apple Juice 5 Gal, Keep Refrigerated, Ripe Liquid Produce
SynchroMed II implantable drug infusion pump, Model 8637-40,
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Two-Bite Pecan Tart 9.2 oz (261g) item number 02023; NL Two-Bite Pecan Tarts 24 x 9.2 oz (261g) item number 02046; Sweet P's Bake Shop Pecan Tarts NET WT 9.2 oz (261g) item number 13076
Two-Bite Pecan Tarts Party Platter 16 x 16.2 (460g) item number 09877
Two-Bite Turtle Brownie Party Platter 16 x 12.2 oz (346g) item number 09904
The Bakery Mini Pecan Tarts Part Platter NET WT 16x 16.2 OZ (460g) item number 08535
Lipari Old Tyme Pepper Jack Mini horn, 2/6#
Lipari Old Tyme Muenster Cheese, 12/8 oz.
Lipari Old Tyme Colby Jack Longhorn, 2/14.5#
Lipari Old Tyme Colby Jack Cheese, 12/8 oz.
Lipari Old Tyme Hot Pepper Cheese, 12/8 oz.
Lipari Old Tyme Pepper Jack Cheese, 12/8 oz.
Lipari Old Tyme Firecracker Jack Mini Horn, 2/6#
Lipari Old Tyme Colby Jack Mini Horn, 2/6#
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Meijer Caesar Salad labeled as Meijer Greek Salad, Single serve salad, packed in plastic containers with printed labels, Keep Refrigerated
Meijer Colby and Colby Jack Deli Cheese 6lb horn; sold from the Meijer store Deli counter, by weight Sold in plastic deli packaging with printed labels
Ham & Cheddar on White Baguette Sandwich 9.2oz retail Plastic packaging Ready to Eat sandwich Keep Refrigerated
Meijer Artisan Made Natural Muenster Cheese 8oz retail Plastic packaging Keep Refrigerated
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data M
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Man
Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Red Blood Cells, Leukocytes Reduced, Irradiated
Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data

Product Quantity
1,627 sites potentially have the affected software
80 BIB and 88 cases of 2 oz immunity shots (total for all products)
283 Caesar salads may be labeled as Greek salads
500 taster cork jars (0.9 oz.); 192 small jars (1.8 oz.), and 78 large jars (6.1 oz.).
371 sites potentially have the affected software
298 sites potentially have the affected versions (290 of those in US)

Reason for Recall
The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits .
Product may have the potential for pathogen growth and toxin formation due to Clostridium botulinum.
Seaquest Seafood Corp is recalling dehydrated and marinated uneviscerated fish because they have the potential to be contaminated with Clostridium botulinum.
Multiple laboratory analysis found multiple instances where various cheeses exceed allowed limits of generic E. coli.
Graceleigh, Inc. dba Sammys Milk is recalling certain lots of Sammys Milk (Baby Food) because of possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal bloom infections or meningitis in infants (under 12 months of age) and it may not provide adequate nutritional levels of iron.
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
French Toast contains frozen strawberries which may be contaminated with Hepatitis A.
Snyder of Berlin is recalling their Buffalo Blue Kettle Cooked Potato Chips after being informed that a milk powder used within a spice blend ingredient may contain Salmonella.
Software issue resulting in the results of one patient potentially being associated with another.
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
The firm stated that they were notified by some of their customers that their product contains metal fragments.
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.
Product has the potential to be contaminated with Listeria monocytogenes.
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
Blood product, manufactured without the entire quantity of additive solution, was distributed.
Blood products, in which donor screening was not done or incorrectly performed, including incorrect ID used during search,prior deferral due to history, were distributed.
Complaints of the 2.0ml tube stopper coming loose during phlebotomy
Certain Gouda Cheese products are being recalled after Saputo was notified by their supplier that the cheese may be contaminated with Listeria monocytogenes.
Blood product, collected from an ineligible donor, was distributed.
Blood product, whose relevant Transfusion-Transmitted Infection Testing was performed incorrectly, was distributed.
The Ingredients statement declared wheat, egg, and milk but the Contains statement declared only wheat. Product contains butter but label does not declare milk.
The Ingredients statement declared wheat, egg, and milk but the Contains statement declared only wheat.
The Ingredients statement declared wheat, and egg but the Contains statement declared only wheat. Product contains butter but label does not declare milk.
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
La Fe Papas Criollos may be contaminated with Listeria Monoctyogenes.
Plateletpheresis products, lacking proper quality control testing, were distributed.
Specific lots of MTS Anti-IgG Card lots that may exhibit a varying low-level activity of anti-complement that may result in a false positive test, were distributed.
Blood products, collected from an ineligible donor, were distributed.
Blood products whose relevant Transfusion-Transmitted Infection Testing was performed, incorrectly, were distributed.
Red Blood Cells, misbranded as to leukoreduction status, were distributed.
Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
Blood products, whose relevant Transfusion-Transmitted Infection testing was performed incorrectly, were distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Misbranded red cells collected by apheresis were distributed.
Dried weevil larvae may be present in the recalled products.
Fuji Food Products is recalling Hawaiian Delight due to a potential Listeria monocytogenes.
Lipari Foods is recalling multiple cheeses because of a supplier's recall of cheese due to potential contamination with Listeria monocytogenes.
Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
Meijer announced it is recalling a recent shipment of its pre-made Caesar salads after discovering they were mislabeled as Greek salads and contain undeclared allergen wheat.
The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
Parmigiano Reggiano (Parmesan) cheese is declared, but milk is not listed on label.
potential contamination with Listeria monocytogenes
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.
Software changes now available to address several issues
The wiring may allow the lamps to turn on with the key switch rather than the timer.
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Failed Dissolution Specifications; 9 month long term stability
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Blood products, tested incorrectly for relevant Transfusion-Transmitted Infections, were distributed.
A customer relayed a complaint of a leaking dialysis tubing connector.
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.
Blood products, associated with incorrectly performed testing for relevant Transfusion-Transmitted Infections, were distributed.
Blood product, in which donor suitability was not adequately determined, was distributed.
Plateletpheresis product, for which the quality control testing for pH did not meet specifications, was distributed.
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.

Code Info
Lot Codes: TTL-D1615 and TTL-H0715; Lot Codes: TTL-L1014 and TTL-K2814
no codes distribution date is 10/21/2016
All versions of Eye Care PACS, Eye Station, and ESIU.
Best before: February 1, 2017 and including up to August 10, 2017
Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
Product Number:119536, Sell By Date: 5/28/17 thru 10/24/17
Product Number: 119836, Sell By Date: 5/28/17 thru 10/24/17
Product Number: 359880, Sell By Date: 5/28/17 thru 10/24/17
Product Number: 359886, Sell By Date: 8/7/17 & 8/15/17
Product Number: 119636, Sell By Date: 5/28/17 thru 10/24/17
Product Number: 126000, Sell By Date: 7/4/17 thru 7/10/17
Product Number: 119736, Sell By Date: 5/28/17 thru 10/24/17
Product Number: 249203, Sell By Date: 5/28/17 thru 10/24/17
Product Number: 119436, Sell By Date: 8/7/17 and 8/15/17
The salads were produced on 02/26/17. This is the only affected date of production. Sell By date: 3/3/17, UPC: 218234-xxxxxx , the last 6 digits will vary, and are determined by weight.
Device Listing D011374 Serial Number: All serial numbers