Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Utah, Idaho, and Wyoming.  No government, VA/govt/military consignees.
Product Code CR046  and Lot Number 152292-53; Date 07/18/16
Product Code 5257 and Lot Number 152789-10 ; Date 08/18/16
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
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
Dimension Troponin 1 (TNI) Flex reagent cartridge
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.
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
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
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.
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.
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.
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.
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.
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
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.
Distributed to the following states: AL, FL, GA, NC, SC, TN
Publix Deli, Artichoke & Spinach dip, 16 oz., plastic clamshell, Manufactured and distributed by Publix Super Markets, Lakeland, FL.
DePuy Mitek, Inc., a Johnson & Johnson Co.
US: AZ, CA, CO, GA, MA, MI, OH, WA  Foreign:  Austria,  Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
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
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
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
Distribution was made nationwide to medical facilities.  There was no foreign/government/military distribution.
98 sites potentially have the affected versions
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.
USA (nationwide) Distribution was made to medical facilities.  There was no foreign/government/military distribution.
Merge OrthoPACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.
160 sites potentially have the affected versions
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.
AL, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MO, NE, NY, OH, OK, PA, SC, TN, TX, WA
GEC TNT Thermanite 60 Capsules Dietary Supplement in clear plastic bottle, UPC: 689466706222.
Product contains DMAA and Methylsynephrine.
Worldwide Distribution - US (Nationwide)  Foreign: South Korea, Taiwan, Thailand
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
Packaging breach may  compromise sterility
Product was distributed at Market Basket Supermarket Stores
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, Inc #816 - Grand River Packaging
Domestic:  IL, IN,  KY, MI, OH, WI,     Foreign:None  VA/DOD: None
Meijer Honey Vanilla Bourbon Pecans, 8.5 oz., 6/case, packed in a stand-up pouch.
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.
Hail Merry Meyer Lemon Miracle Mini Tarts, 6 tartlets per tray packaged in clear plastic molded trays.
Product is being recalled due to undeclared cashews.
CA , NJ, IL, GA, TX, and Mexico, Philippines, Venezuela, Dominican Republic, Panama, Nicaragua, Belize.
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
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.
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.
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
The firm was notified that the product may contain peanuts.
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
Firm was notified by customer of a positive Salmonella result obtained when testing of the product on receipt.
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.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Southern Grove Cashew Halves & Pieces with Sea Salt, Net Weight 8.0 oz. (227 grams)
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.
Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory      Device accessory that elevates monitor for healthcare professionals.
Elevating Monitor Suspension column dropping and will not rise back up.
SKF Telescopic Pillar P/N ending in -003
Aurora Area Blood Bank Dba Heartland Blood Centers
Red blood cell, for which WBC quality control testing was pending, was distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
Red blood cells, for which quality control testing was not performed, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
US and Canada  Beautycounter sells its products direct to consumer and as employee gifts
Internal testing  of the product after noticing an off odor discovered the bacteria Pluralibacter gergoviae in the product
Lot # 1626003 for both sizes, Expiry date 9/19/2019.
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
Presence of foreign substance: glass particle
Blood Bank Of San Bernardino And Riverside Counties
Misbranded red blood cells, were distributed.