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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
High RiskFDA
Zimmer Gmbh
V-TEK", Micro-countersink, AO, Item Number 28.66.113
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2x95mm, round shaft, Item Number 502015619
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
CBS high, countersink, cannulated, round-shaft, Item Number 503004342
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2.8x120mm, AO, Item Number 502015628
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, 2.5x135mm, AO, Item Number 502015142
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
Medical Devices·0 affected·Apr 8, 2019
CriticalFDA
Integra Lifesciences Corp.
MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and M...
Medical Devices·42,102 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, 3.2x145mm, AO, Item Number ST502015650
Medical Devices·0 affected·Apr 8, 2019
CriticalFDA
Integra Lifesciences Corp.
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 ...
Medical Devices·42,102 affected·Apr 8, 2019
High RiskFDA
Compass Health Brands (corporate Office)
MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum,...
Medical Devices·3,889 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2x95mm, AO, Item Number 502015623
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, contra-angle, 1.5x85mm, Item Number 502015706
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Compass Health Brands (corporate Office)
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 3x90mm, AO, Item Number 502015631
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
CBS micro, countersink, cannulated, AO, Item Number 503004541
Medical Devices·0 affected·Apr 8, 2019
High RiskFDA
Boston Scientific Corporation
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System ...
Surgical Devices·1 affected·Apr 8, 2019
High RiskFDA
Zimmer Gmbh
Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635
Medical Devices·0 affected·Apr 8, 2019