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
136
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 136 (28%) 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.

251–275 of 478

  • 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-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-2005-2018·2018-06-06

    Arrow International Recalls Triple-Lumen CVC Kits Due to Packaging Defect

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

    Product
    ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2018·2018-06-06

    Arrow International Recalls Sheath Adapters Due to Compromised Sterility

    Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise product sterility.

    Product
    Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

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

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2018·2018-06-06

    Arrow JACC IV Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.

    Product
    ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2018·2018-06-06

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Sterility Concerns

    Arrow International Inc is recalling VPS Rhythm ECG Accessory Packs because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 35 other countries.

    Product
    VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
    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-2002-2018·2018-06-06

    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), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2018·2018-06-06

    Arrow International Extension Line Slide Clamps Recalled for Sterility Concerns

    Arrow International is recalling Extension Line Slide Clamps because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Extension Line Slide Clamps; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2018·2018-06-06

    Arrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect

    Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Packaging Issues

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling specific lots of Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2018·2018-06-06

    Arrow Radial Artery Catheterization Kits Recalled for Packaging Defects

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

    Product
    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2004-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

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

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH
    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-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-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-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
  • ModerateFDA (Devices)·Z-1961-2018·2018-06-06

    Arrow International Recalls Epidural Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 epidural needles because unsealed packaging may compromise product sterility. The recall covers distribution in the US and 35 other countries.

    Product
    Epidural Needle; Product Codes: AN-05501 and AN-05505
    Category
    Medical Device
    Distribution
    Distributed nationwide