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.

351–375 of 478

  • ModerateFDA (Devices)·Z-0653-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

    Arrow International Inc is recalling 5,926 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-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0654-2018·2018-02-28

    Arrow Multi Lumen CVC Kit Recalled for Incorrect Springwire Guide

    Arrow International Inc. is recalling 5,926 Arrow Multi Lumen CVC Kits because they may contain the incorrect Springwire Guide.

    Product
    Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0649-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0652-2018·2018-02-28

    Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

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

    Product
    Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0658-2018·2018-02-28

    Arrow International Recalls Hemodialysis Catheterization Kits with Incorrect Guide

    Arrow International Inc is recalling specific lots of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2018·2018-02-28

    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
    Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2018·2018-02-28

    Arrow International Recalls Central Venous Catheters With Incorrect Guide

    Arrow International Inc. is recalling 5,926 ARROWg+ard Blue Plus Multi Lumen CVC kits that may contain the incorrect Springwire Guide.

    Product
    ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0601-2018·2018-02-21

    Arrow International Recalls PICC Catheter Kits Due to Incorrect Components

    Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or type, potentially delaying patient treatment.

    Product
    ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2018·2018-02-21

    Arrow Radial Artery Catheterization Set Recalled for Foreign Matter

    Arrow International Inc is recalling Radial Artery Catheterization Sets due to the presence of loose polypropylene foreign matter above release specifications.

    Product
    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0602-2018·2018-02-21

    Arrow PICC Catheter Recall Due to Incorrect Component Kits

    Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.

    Product
    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2018·2017-12-06

    Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error

    Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.

    Product
    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2018·2017-12-06

    Arrow VPS Access Kit Recalled for Potential Size Mismatch

    Arrow International is recalling VPS Access Kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2018·2017-12-06

    Arrow PICC Kits Recalled for Potential Incorrect Sheath Size

    Arrow International is recalling specific PICC kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2018·2017-12-06

    Arrow PICC Recall Due to Potential Incorrect Peel-Away Sheath Size

    Arrow International is recalling specific lots of ARROW PICC powered by ARROW VPS Stylet kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2698-2017·2017-07-19

    Arrow Recalls EVOLUTION Pressure Injectable PICC Catheters Due to Hub Tab Detachment

    Arrow International is recalling EVOLUTION Pressure Injectable PICC catheters because the peel-away component hub tabs may prematurely detach during use.

    Product
    Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2331-2017·2017-06-21

    Arrow Recalls PICC Kits Due to Potential Packaging Seal Defects

    Arrow International is recalling Pressure Injectable PICC Kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2017·2017-06-21

    Arrow International Recalls ARROWg+ard Blue CVC Kits for Central Venous Access

    Arrow International Inc is recalling ARROWg+ard Blue CVC Kits used for short-term central venous access. The recall affects 27,485 units distributed in the U.S. and 4,371 units internationally.

    Product
    ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2017·2017-06-21

    Arrow Pressure Injectable PICC Kit Recalled for Quality Concerns

    Arrow International Inc. is recalling Arrow Pressure Injectable PICC Kits due to a Class II recall classification. The devices are used for intravenous therapy and blood sampling.

    Product
    Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2017·2017-06-21

    Arrow International Recalls Hemodialysis Catheter Kits Due to Packaging Seal Issues

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

    Product
    1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2017·2017-06-21

    Arrow Arterial Catheterization Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Catheterization Kits because packaging defects may compromise sterility.

    Product
    Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2017·2017-06-21

    Arrow Recalls Single-Lumen Central Venous Catheter Kits Due to Packaging Seal Issues

    Arrow International is recalling single-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2017·2017-06-21

    Arrow Multi-Lumen CVC Kit Recalled by FDA for Medical Device Safety

    Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits under FDA Class II recall Z-2336-2017. The devices are used for short-term central venous access.

    Product
    Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2333-2017·2017-06-21

    Arrow International Recalls Central Venous Access Kits Due to Packaging Seal Issues

    Arrow International is recalling specific central venous access kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2332-2017·2017-06-21

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Seal Issues

    Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard
    Category
    Medical Device
    Distribution
    Distributed nationwide