Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the An-owEVOLUTIONTM Pressure
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIAGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infe
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIAGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; fr
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar,
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blo
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; i
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; f
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infu
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIArrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusions of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications;
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- 2017-06-14FDA-DeviceArrow International IncClass IIPercutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters. The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections,
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
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