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.

201–225 of 478

  • HighFDA (Devices)·Z-0954-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 19 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 8 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2019·2019-03-06

    Arrow AutoFuser Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling 9 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2019·2019-01-23

    Arrow Pediatric Central Venous Catheter Recalled for Incorrect Labeling

    Arrow International Inc. is recalling specific lots of pediatric central venous catheters because the lidstock labels list incorrect priming volumes and flow rates.

    Product
    Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0468-2019·2018-11-21

    Arrow Multi-Lumen CVC Kit Recalled for Labeling Inconsistencies

    Arrow International is recalling 3,640 units of the AGB+ Multi-Lumen CVC Kit because some labels incorrectly state the spring-wire guide size as .032 instead of .025.

    Product
    Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0282-2019·2018-11-07

    Arrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error

    Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits because shipping documentation listed an incorrect expiration date, though the product lidstock is correct.

    Product
    Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3199-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion

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

    Product
    4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-3197-2018·2018-09-26

    Arrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.

    Product
    ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3200-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Type

    Arrow International is recalling 5.5 Fr x 5.5 Fr x 40 cm double-lumen PICC Kits because they may contain the wrong catheter type, potentially delaying treatment.

    Product
    5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2886-2018·2018-08-29

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International is recalling 166 kits of pediatric central venous catheters because the packaging incorrectly identifies the catheter length.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is i
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2819-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Issues

    Arrow International is recalling 5,507 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous she
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects

    Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous shea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2018·2018-08-08

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error

    Arrow International is recalling 60 units of Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex but is labeled as latex-free.

    Product
    Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2385-2018·2018-07-18

    Arrow International Recalls Midline Catheter Kits Due to Labeling Issues

    Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2382-2018·2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs for Labeling Issues

    Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2383-2018·2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Labeling Issues

    Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2384-2018·2018-07-18

    Arrow International Recalls VPS TipTracker Stylet Accessory Due to Labeling Issues

    Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2336-2018·2018-07-11

    Arrow International Recalls Multi-Lumen Central Venous Catheter Sets

    Arrow International is recalling 1,200 multi-lumen central venous catheter sets due to increased resistance during insertion, which may cause procedural delays.

    Product
    Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
    Category
    Medical Device
    Distribution
    1 state
  • 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-1981-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    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-PVH and ASK-15703-PNYP
    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-2000-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
    Category
    Medical Device
    Distribution
    Distributed nationwide