The Recall Desk

FDA (Devices) recall action 79512

Arrow International Inc recalled 14 products on 2018-04-18

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products
14
Announced
2018-04-18
Critical
0
Units
—

Why these products were recalled

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–14 of 14

  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Central Venous Access Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits because the catheters may not be completely sealed, compromising sterility.

    Product
    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3)…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow MAC Two-Lumen Central Venous Access Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of MAC Two-Lumen Central Venous Access Kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Arterial Catheterization Kits Due to Sterility Concerns

    Arrow International Inc is recalling specific lots of arterial catheterization kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Certain Lots of ARROWg+ard Blue CVC Kits

    Arrow International is recalling specific lots of ARROWg+ard Blue Central Venous Catheter (CVC) kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Certain Lots of Cardiovascular Catheters for Sterility Concerns

    Arrow International Inc is recalling specific lots of cardiovascular catheters because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Two-Lumen PICC Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of two-lumen PICC kits because the catheters may not be completely sealed, potentially compromising sterility.

    Product
    Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Certain Lots of Central Venous Catheter Kits

    Arrow International is recalling specific lots of central venous catheter kits because they may not be completely sealed, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7)…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits

    Arrow International is recalling specific lots of AGB+ central venous catheter kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Arrowg+ard Blue PSI Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue PSI Kits because the catheters may not be completely sealed, preventing a guarantee of sterility.

    Product
    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow International Recalls Certain Central Venous Catheterization Kits

    Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially compromising sterility.

    Product
    (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow PICC Kit Recall Due to Potential Sterility Seal Failure

    Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's sterility cannot be guaranteed.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-18

    Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of hemodialysis catheterization kits because they may not be completely sealed, potentially compromising sterility.

    Product
    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
    Category
    Distribution
    1 state