Device Recall ARROWgard Blue PLUS

  • Model / Serial
    Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States in the state of FL.
  • Product Description
    ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG || Product Usage: || The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). 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 CRBSIs 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

7 devices with a similar name

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  • Model / Serial
    product number CDC-42802-P1A, lot number 23F14A0063
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
  • Manufacturer
  • Model / Serial
    Material Number ASK-46702-AH
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ARROWg+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; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
  • Manufacturer
  • Model / Serial
    Material Number CDA-21242-1A
  • 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 Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
  • Manufacturer
  • Model / Serial
    Material number ASK-46702-AH
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ARROWg+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; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/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
  • Manufacturer
  • Model / Serial
    CDA-42802-P1A CDA-42854-P1A CDA-45703-P1A 13F16K0239 13F16L0285 13F17C0318 13F16L0071 13F16M0048 13F17E0124 13F17F0497 13F17G0428 13F17H0387 13F16K0306 13F16L0091 13F17A0167 13F17B0145 13F17C0174 13F17C0466 13F17E0095 13F17F0261 13F17G0090 13F17G0541 13F17H0566 CDA-47702-P1A  13F17B0249
  • 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 PLUS || Pressure Injectable Two- Lumen CVC 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
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