Device Recall ARROWgard Blue MAC

  • Model / Serial
    CDA-21242-1A 13F16L0209 13F17F0437
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in the states of OH, FL, SC, TX, KY, NJ, MI
  • Product Description
    ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit || Product Usage: || The Arrow¿ 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 infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
  • Manufacturer
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    510K # K011761 and Material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A
  • Product Classification
  • 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
  • Model / Serial
    Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A  Device Listing D025768
  • Product Classification
  • 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