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High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy ...
Medical Devices·3,940 affected·Apr 11, 2019
High RiskFDA
Lamb Weston Bsw Llc
Lamb s Supreme Potato Tater Puffs, item # H30, packaged in 5-pound unprinted KRAFT paper bags, 6 bags to a case, sold as a foodservice it...
Produce·22,789 affected·Apr 10, 2019
High RiskFDA
Uromedica Inc.
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through wh...
Medical Implants·11 affected·Apr 10, 2019
High RiskFDA
Stryker Neurovascular
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufact...
Surgical Devices·1,405 affected·Apr 10, 2019
High RiskFDA
Stryker Neurovascular
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufact...
Surgical Devices·1,405 affected·Apr 10, 2019
High RiskFDA
American Pasteurization Company, Llc
Mediterranean Brands Callaloo Greens, Product 6017. Net Weight 15.0 lbs (6.90 Kgs). Keep Frozen. Manufactured for: MBI, Glenview, IL ...
Frozen Food·119 affected·Apr 9, 2019
High RiskFDA
Cook Inc.
Thoracentesis Set, RPN C-THS-850, Order # G03286
Medical Devices·5 affected·Apr 9, 2019
High RiskFDA
Cook Inc.
Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
Surgical Devices·2 affected·Apr 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for ...
Cardiac Devices·459 affected·Apr 9, 2019
High RiskFDA
Cook Inc.
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Surgical Devices·83 affected·Apr 9, 2019
High RiskFDA
Quidel Cardiovascular Inc
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular I...
Medical Devices·123 affected·Apr 9, 2019
High RiskFDA
Cook Inc.
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Surgical Devices·2 affected·Apr 9, 2019
High RiskFDA
Microbiologics Inc
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent AC...
Medical Devices·249 affected·Apr 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography system...
Cardiac Devices·459 affected·Apr 9, 2019
High RiskFDA
Laduree Usa
Frozen Poppy Seed Bread (57 grams), UPC Codes: (01)03556420003673(15)191122(10)181122(91)0937326, Lot 22112018
Bakery & Grains·51 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customc...
Drugs·19 affected·Apr 8, 2019
High RiskFDA
American Health Packaging
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columb...
Oral Drugs·2,203 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. B...
Drugs·12 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Custo...
Drugs·3 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customc...
Drugs·32 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea ...
Supplements·8 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL...
Drugs·16 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, ...
Drugs·4 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compoun...
Drugs·5 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea ...
Supplements·2 affected·Apr 8, 2019
High RiskFDA
Customceutical Compounding
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customc...
Drugs·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, contra-angle, 1.5x85mm, Item Number ST502015706
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 3x90mm, AO, Item Number ST502015631
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Compass Health Brands (corporate Office)
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System ...
Surgical Devices·3 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 3x90mm, round shaft, Item Number 502015630
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 4x120mm, AO, Item Number ST502015402
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser Syste...
Surgical Devices·2 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
CBS 7.5 tap, cannulated, AO, Item Number 503002041
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
Medical Devices·0 affected·Apr 8, 2019