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High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-...
Oral Drugs·1,233,107 affected·Mar 20, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx ...
Oral Drugs·444,201 affected·Mar 20, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx ...
Oral Drugs·299,112 affected·Mar 20, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx ...
Oral Drugs·452,269 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral a...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Roho Inc.
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Re...
Medical Devices·5,646 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard An...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circ...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits ven...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and C...
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) Catheter The Arrow(r) CVC is indicated to provid...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the periphera...
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 and Sharps Safe...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intende...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic T...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral...
Medical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral a...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Anti...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access ...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideTh...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) cen...
Surgical Devices·43,394 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 Arrow(r) CVC ...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular ...
Medical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral a...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide s...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral a...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) ce...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier ...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide s...
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. The intended u...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous S...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard B...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation f...
Surgical Devices·43,394 affected·Mar 20, 2017
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
Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safet...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation ...
Surgical Devices·0 affected·Mar 20, 2017
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