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High RiskFDA
Arrow International Inc
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the periphera...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulati...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maxima...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Zimmer Dental Inc
Tapered SwissPlus Implant System, Model No. SPB10
Medical Implants·188 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial cathete...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended ...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Intr...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety ...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Global Marketing Enterprises, Inc.
40/50 ct/kg (21/25 ct/lb) Farm Raised Head-On Shrimps, Keep Frozen, Must be fully cooked before serving. 1.02 kg, 2.24 lb. Packed by: ...
Seafood·1,173 affected·Mar 17, 2017
High RiskFDA
Shire
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Drugs·3 affected·Mar 17, 2017
High RiskFDA
Akorn, Inc.
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest,...
Ophthalmic Drugs·107,940 affected·Mar 17, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Medical Devices·38,415 affected·Mar 17, 2017
High RiskFDA
Medtronic Neuromodulation
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The le...
Medical Implants·86,024 affected·Mar 17, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by...
Surgical Devices·310 affected·Mar 17, 2017
High RiskFDA
Eden Spine Europe Sa
GIZA Vertebral Body Replacement
Medical Devices·1,839 affected·Mar 17, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for u...
Medical Devices·7,508 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·172 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·20 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·440 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·169 affected·Mar 16, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usa...
Diagnostic Devices·13,064,500 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·100 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·500 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·1,170 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·260 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·16 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·990 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·4,065 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·1,520 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·700 affected·Mar 16, 2017
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc....
Injectable Drugs·83,188 affected·Mar 15, 2017
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx ...
Oral Drugs·32,628 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Danish SRK. General and Plastic S...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Spanish SRK General and Plastic Sur...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Richard-allan Scientific Company
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chr...
Diagnostic Devices·390 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in ...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic ...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish SRK General and Plastic S...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Greek SRK General and Plastic Sur...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Swedish SRK General and Plastic Surge...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in cr...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017