Recalling Firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Meijer, Inc #816 - Grand River Packaging
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood Bank Of San Bernardino And Riverside Counties

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

Distribution Pattern
Utah, Idaho, and Wyoming. No government, VA/govt/military consignees.
Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
Worldwide Distribution - USA (nationwide) and to the countries of : ARGENTINA, ARMENIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, CANADA, CHINA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEM. REP. OF THE CON, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VIETNAM
Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
Worldwide Distribution - US (nationwide): including states of: AK, AL, AR, AZ, CA, CO, CT, DC,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, ME, MI, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY,and UK.
Distributed to the following states: AL, FL, GA, NC, SC, TN
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
AL, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MO, NE, NY, OH, OK, PA, SC, TN, TX, WA
Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
Product was distributed at Market Basket Supermarket Stores
Domestic: IL, IN, KY, MI, OH, WI, Foreign:None VA/DOD: None
CA , NJ, IL, GA, TX, and Mexico, Philippines, Venezuela, Dominican Republic, Panama, Nicaragua, Belize.
Products were shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, OR, SC, TN, TX, UT, VA, WA, WV & WY.
ALDI Distribution Centers. 3/6/2017 Hinckly OH 3/6/2017 Hanes City FL 3/8/2017 Frederick MD 3/8/2017 OFallon MO 3/28/2017 OFallon MO 3/28/2017 Frederick MD 4/3/2017 Hinckly OH 4/3/2017 Salisbury NC 4/3/2017 Batavia IL 4/6/2017 Frederick MD 4/7/2017 Salisbury NC 4/7/2017 Valparaiso IN 4/7/2017 Royal Park FL 4/7/2017 Saxonsburg PA 4/7/2017 Frederick MD 4/20/2017 Batavia IL 4/21/2017 Hanes City FL 4/28/2017 Jefferson GA 4/28/2017 Webberville MI
Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
US and Canada Beautycounter sells its products direct to consumer and as employee gifts

Product Description
Commercial Rabbit, Complete feed for all rabbits with high energy requirements, 50 lb bag, Packaged in white, poly blend bags, Store feed in a dry area, Distributed by Cache Commodities, Inc., Ogden, Utah
Dimension Troponin 1 (TNI) Flex reagent cartridge
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Dimension Vista Ferritin (FERR) Flex reagent cartridge
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
Dimension Vista Estradiol (E2) Flex reagent cartridge
Dimension Vista Prolactin (PRL) Flex reagent cartridge
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents
Publix Deli, Artichoke & Spinach dip, 16 oz., plastic clamshell, Manufactured and distributed by Publix Super Markets, Lakeland, FL.
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
GEC TNT Thermanite 60 Capsules Dietary Supplement in clear plastic bottle, UPC: 689466706222.
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
Market Basket moreBAR Dark Chocolate Peanut , 4.3 oz. bar
NutriHeal OPTIMAL CHOLESTEROL Traditional Vegetarian Blend Herbal Supplement, 60 Tablets. Distributed By: Herbmed USA Company Inc.
Master Carton is Labeled As: LOBSTER FLAVORED BALL DISTRIBUTED EXCLUSIVELY BY: H & C FOOD INC. BROOKLYN, NY 11237 KEEP FROZEN AT -18 C
Meijer Honey Vanilla Bourbon Pecans, 8.5 oz., 6/case, packed in a stand-up pouch.
Hail Merry Meyer Lemon Miracle Mini Tarts, 6 tartlets per tray packaged in clear plastic molded trays.
Kleancolor Frameous Lash & Brow, CLEAR LASH AND BROW MASCARA; NET WT 0.41 fl. oz. Item number: MS1810 UPC Codes: 8-10236-00810-3; Made in China
Private Selection Peruvian Inspired Aji Amarillo Culinary Spice Paste NET WT 4 OZ (113g) INGREDIENTS: SOY SAUCE***CONTAINS: SOY. DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 MADE IN CANADA
PRIVATE SELECTION AFRICAN - INSPIRED PERI PERI CHILI CULINARY SPICE PASTE NET WT 4 OZ (113g) UPC 0 11110 80699 4 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 MADE IN CANADA
Blue Diamond Almonds Blanc DCD FN C (blanched diced fine); NET WT 11.34 Kg, 25 lbs. corrugated carton with poly liner; Product of the USA. Blue Diamond Almonds, Sacramento, CA
Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.
Southern Grove Cashew Halves & Pieces with Sea Salt, Net Weight 8.0 oz. (227 grams)
Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
joray fruit roll FRUIT PUNCH flavor NET WT 1 OZ. (28g). UPC# 0 51063 50009 9.
Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344

Product Quantity
98 sites potentially have the affected versions
160 sites potentially have the affected versions

Reason for Recall
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
Product contains DMAA and Methylsynephrine.
Packaging breach may compromise sterility
The firm initiated a voluntary recall of Meijer Honey Vanilla Bourbon Pecans, 8.5 oz., packed in a stand up pouch, due to mislabeling. The label declared cream, milk, and eggs, which were not part of the original formula. The label lacked the following ingredients: Spices, Artificial Flavors, Garlic Powder, Onion Powder, Dextrose, Worcestershire Sauce, Corn Syrup, Salt, Carmel Color, Sugar, Tamarind, Natural Flavor, Malic Acid, Olive Oil, Molasses Sucralose, Bourbon Whiskey, Sulfites & Celery Seeds.
Product is being recalled due to undeclared cashews.
FDA sampling found mold to be present in the product at levels above the regulatory limits for eye-area products.
Misbranded plasma product was distributed.
The firm was notified that the product may contain peanuts.
Firm was notified by customer of a positive Salmonella result obtained when testing of the product on receipt.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
The firm received notification from a consumer finding a glass fragment in Southern Grove Cashew Halves, 8.oz. Source of glass is unknown. It is suspected the glass fragments came in with the raw material.
Elevating Monitor Suspension column dropping and will not rise back up.
Red blood cell, for which WBC quality control testing was pending, was distributed.
Red blood cells, for which quality control testing was not performed, were distributed.
Internal testing of the product after noticing an off odor discovered the bacteria Pluralibacter gergoviae in the product
Presence of foreign substance: glass particle
Misbranded red blood cells, were distributed.

Code Info
Product Code CR046 and Lot Number 152292-53; Date 07/18/16
Product Code 5257 and Lot Number 152789-10 ; Date 08/18/16
SKF Telescopic Pillar P/N ending in -003
Lot # 1626003 for both sizes, Expiry date 9/19/2019.