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High RiskFDA
U.b.c Food Distributors, Llc
Mango flavored gelatin mix desert
Food·316 affected·Oct 15, 2014
High RiskFDA
U.b.c Food Distributors, Llc
Strawberry flavored gelatin mix desert
Produce·735 affected·Oct 15, 2014
High RiskFDA
Vision Rt Inc
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and preci...
Medical Devices·7 affected·Oct 15, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Medical Devices·3,082 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The A...
Medical Implants·10,085 affected·Oct 15, 2014
High RiskFDA
American Medical Systems, Inc.
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 724041...
Medical Implants·2,165 affected·Oct 15, 2014
High RiskFDA
Vann Healthcare Services Inc
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare ...
Drugs·7 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·1 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, ...
Injectable Drugs·340,272 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
Injectable Drugs·784,920 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
Injectable Drugs·153,504 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Injectable Drugs·16,487,040 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
Injectable Drugs·301,560 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·900 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, N...
Injectable Drugs·823,296 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
Injectable Drugs·6,193,416 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0...
Injectable Drugs·275,448 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045...
Injectable Drugs·305,664 affected·Oct 14, 2014
High RiskFDA
Vann Healthcare Services Inc
Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drugs·410 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL...
Injectable Drugs·152,172 affected·Oct 14, 2014
High RiskFDA
Hospira Inc.
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., La...
Injectable Drugs·836,460 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: ...
Medical Devices·147 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H...
Medical Devices·255 affected·Oct 14, 2014
High RiskFDA
Zimmer, Inc.
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial ...
Medical Devices·4,961 affected·Oct 14, 2014
High RiskFDA
St Jude Medical
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Surgical Devices·26 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine i...
Medical Devices·29 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3...
Medical Devices·22 affected·Oct 14, 2014
High RiskFDA
Medtronic Vascular
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Surgical Devices·11 affected·Oct 13, 2014
High RiskFDA
Whole Foods Market Brand 365, Llc
365 Organic Raisin Granola in 17 ounce (482 gram) cardboard cartons; 12 cartons per case. UPC: 099482448738
Bakery & Grains·20,244 affected·Oct 10, 2014
High RiskFDA
Contract Packaging Resources Inc.
Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Ro...
Oral Drugs·11,640 affected·Oct 10, 2014
High RiskFDA
American Medical Systems, Inc.
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 70...
Medical Implants·184 affected·Oct 10, 2014
High RiskFDA
Silver Star Brands
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injur...
Medical Devices·129 affected·Oct 10, 2014
High RiskFDA
Us Infusion Inc Dba Trucare Biomedix-usa
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Medical Devices·62,700 affected·Oct 10, 2014
High RiskFDA
California Olive And Vine, Llc
Williams Sonoma Pumpkin Seed Pesto 8 oz. glass jar
Food·460 affected·Oct 9, 2014
High RiskFDA
Micro Labs Usa, Inc S
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by:...
Oral Drugs·11,328 affected·Oct 9, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Diagnostic Devices·10,515 affected·Oct 9, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system fea...
Medical Devices·708 affected·Oct 9, 2014
High RiskFDA
Zimmer, Inc.
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability d...
Surgical Devices·138 affected·Oct 9, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Diagnostic Devices·10,515 affected·Oct 9, 2014
High RiskFDA
Teva Pharmaceuticals Usa
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet ...
Oral Drugs·19,545 affected·Oct 8, 2014
High RiskFDA
Ad-tech Medical Instrument Corporation
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Elect...
Medical Devices·13 affected·Oct 8, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunct...
Medical Devices·3,138 affected·Oct 8, 2014
High RiskFDA
Ebi, Llc
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also availa...
Medical Implants·2,816 affected·Oct 8, 2014
High RiskFDA
Zee Medical Products Inc
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories,...
Oral Drugs·43,752 affected·Oct 7, 2014
High RiskFDA
C.r. Bard, Inc.
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture st...
Medical Devices·86 affected·Oct 7, 2014
High RiskFDA
Mako Surgical Corporation
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the p...
Medical Implants·404 affected·Oct 7, 2014
High RiskFDA
Mako Surgical Corporation
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically...
Medical Implants·404 affected·Oct 7, 2014
High RiskFDA
Zimmer, Inc.
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedur...
Medical Implants·618 affected·Oct 7, 2014