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.

301–325 of 478

  • HighFDA (Devices)·Z-1333-2018·2018-04-18

    Arrow International Recalls Certain Lots of ARROWg+ard Blue CVC Kits

    Arrow International is recalling specific lots of ARROWg+ard Blue Central Venous Catheter (CVC) kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1332-2018·2018-04-18

    Arrow International Recalls Certain Lots of Cardiovascular Catheters for Sterility Concerns

    Arrow International Inc is recalling specific lots of cardiovascular catheters because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1325-2018·2018-04-18

    Arrow International Recalls Two-Lumen PICC Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of two-lumen PICC kits because the catheters may not be completely sealed, potentially compromising sterility.

    Product
    Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1326-2018·2018-04-18

    Arrow International Recalls Certain Lots of Central Venous Catheter Kits

    Arrow International is recalling specific lots of central venous catheter kits because they may not be completely sealed, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7)…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1335-2018·2018-04-18

    Arrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits

    Arrow International is recalling specific lots of AGB+ central venous catheter kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1329-2018·2018-04-18

    Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1334-2018·2018-04-18

    Arrow International Recalls Arrowg+ard Blue PSI Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue PSI Kits because the catheters may not be completely sealed, preventing a guarantee of sterility.

    Product
    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1331-2018·2018-04-18

    Arrow International Recalls Certain Central Venous Catheterization Kits

    Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially compromising sterility.

    Product
    (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1327-2018·2018-04-18

    Arrow PICC Kit Recall Due to Potential Sterility Seal Failure

    Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's sterility cannot be guaranteed.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1336-2018·2018-04-18

    Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns

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

    Product
    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1281-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 930 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life instead of 24 months.

    Product
    Radial Artery Catheterization Kit; Model: AK-04018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement.

    Product
    Radial Artery Catheterization Kit; Model: AK-04020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04020-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1286-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2018·2018-04-11

    Arrow Arterial Access Tray Recall for Povidone Iodine Shelf Life Labeling

    Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.

    Product
    Arterial Access Tray, introducer catheter; Model: GU-04020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1285-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2018·2018-04-04

    Arrow Endurance Peripheral Catheter Systems Recalled for Missing Safety Latch

    Arrow International is recalling specific lots of Endurance Extended Dwell Peripheral Catheter Systems because they may be missing a safety latch designed to prevent sharps injuries.

    Product
    ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1166-2018·2018-03-28

    Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists

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

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access 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-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