Devices

Device Recall ARROWgard Blue MAC TwoLumen Central Venous Access Kit

  • Model / Serial
    510K # K011761 and Material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit || The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
  • Manufacturer
    Arrow International Inc
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall ARROWgard Blue MAC TwoLumen Central Venous Access Kit
  • Model / Serial
    Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A  Device Listing D025768
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada
  • Product Description
    1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit || 2) ARROWg+ard Blue PSI Kit || 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit || 4) ARROWg+ard Blue PSI Kit || The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
  • Manufacturer
    Arrow International Inc