The Recall Desk

Manufacturer

ARROW INTERNATIONAL Inc.

478 recalls in our database name ARROW INTERNATIONAL Inc. as the manufacturing or recalling firm.

What the numbers show

Total
478
Critical
1
Severe
146
Most recent
2024-10-02

Of the 478 recalls from ARROW INTERNATIONAL Inc. we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 146 (31%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

226–250 of 478

  • HighFDA (Devices)·Z-1989-2018·2018-06-06

    Arrow International Recalls Pressure Injectable CVC Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2018·2018-06-06

    Arrow International Recalls MAC Two-Lumen Central Venous Access Kits

    Arrow International Inc is recalling MAC Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2018·2018-06-06

    Arrow Maximal Barrier Drapes Recalled for Potential Sterility Compromise

    Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00376-SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Risk

    Arrow International Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2018·2018-06-06

    Arrow Arterial Line Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2018·2018-06-06

    Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Codes: ASK-04020-DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2018·2018-06-06

    Arrow PSI Kit Recall Due to Potential Sterility Compromise

    Arrow International is recalling 416,055 PSI kits because unsealed packaging may have compromised sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2018·2018-06-06

    Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect

    Arrow International is recalling 416,055 continuous nerve block needles because unsealed packaging may compromise product sterility.

    Product
    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Defect

    Arrow International is recalling 416,055 central venous catheter kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2018·2018-06-06

    Arrow PICC Sets Recalled Due to Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 PICC sets because unsealed packaging may have compromised product sterility.

    Product
    ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2018·2018-06-06

    Arrow International Recalls 9 Fr. Radiopaque Polyurethane Sheath Due to Packaging Defect

    Arrow International Inc is recalling 416,055 units of 9 Fr. Radiopaque Polyurethane Sheath/Dilator because unsealed packaging may compromise product sterility.

    Product
    9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWgard Blue PLUS Multi-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2018·2018-06-06

    Arrow Multi-Lumen Central Venous Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2018·2018-06-06

    Arrow International Recalls Maximal Barrier Drapes Due to Packaging Defect

    Arrow International is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall covers lots distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Code: ASK-01000-UPMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2018·2018-06-06

    Arrow Central Venous Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc. is recalling ARROWg+ard Blue Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2018·2018-06-06

    Arrow International Recalls Clear Fenestrated Drapes Due to Packaging Issues

    Arrow International Inc is recalling 416,055 Clear Fenestrated Drapes with Adhesive because unsealed packaging may compromise product sterility.

    Product
    Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Unsealed Packaging

    Arrow International Inc. is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00001-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 7Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
    Category
    Medical Device
    Distribution
    Distributed nationwide