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.

326–350 of 478

  • ModerateFDA (Devices)·Z-1160-2018·2018-03-28

    Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

    Arrow International is recalling 18,124 percutaneous sheath introducer kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1161-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guides

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical procedure notes and checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2018·2018-03-28

    Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information

    Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.

    Product
    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 cat
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1164-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation

    Arrow International is recalling 18,124 central venous catheter kits because they lack required clinical guidance documents. The recall is nationwide.

    Product
    Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2018·2018-03-21

    Arrow CVC Kit Recall for Missing Lot and UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Quad- 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 i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0995-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Label Information

    Arrow International is recalling 23,904 central venous catheter kits because some units may be missing stickers with lot, expiration, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0994-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 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 i
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0996-2018·2018-03-21

    Arrow PICC Kits Recalled for Missing Lot and Expiration Labels

    Arrow International is recalling 23,904 PICC kits because some units are missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central v
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0998-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- 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 flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1002-2018·2018-03-21

    Arrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels

    Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard Blue 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 chemothera
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1001-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ Large-Bore Multi-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 fl
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1004-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Stickers

    Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    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
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0999-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Information

    Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Quad- 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 fluid
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0997-2018·2018-03-21

    Arrow International Recalls Central Venous Catheter Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venou
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1003-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- 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 flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1000-2018·2018-03-21

    Arrow International Recalls Central Venous Access Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous access kits because some units may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    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 infus
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0690-2018·2018-02-28

    Arrow International Recalls PICC Powered by VPS Stylet Kits

    Arrow International is recalling 601 PICC powered by VPS Stylet kits because they may contain an incorrect catheter length.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0657-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.

    Product
    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2018·2018-02-28

    Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

    Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide because they may contain the incorrect Springwire Guide.

    Product
    Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0647-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

    Arrow International Inc is recalling 5,926 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide