Device Recall AGB Pressure Injectable MultiLumen CVC Kit

  • Model / Serial
    Material number CDA-42703-P1A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AGB+ 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 infections nor is it indicated for long-term use (>30 days). The ARROWg+ard Blue PLUS¿ Multiple-Lumen 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 (CRBSI). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSI's compared to the original ARROWg+ard Blue¿ catheter has not been studied
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

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  • Model / Serial
    Material number CA-42703-P1A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AGB+ 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
  • Manufacturer