Skip to main content

FDA recall, , Moderate risk

Arrow International Catheters and Introducer Kits

Arrow International Catheters and Introducer Kits have liquid adhesive that was incorrectly manufactured.

Summary by Recall Canary from the FDA notice

What happened

Arrow International, LLC of Morrisville, North Carolina, recalled several catheter and introducer kits because a supplier incorrectly manufactured the liquid adhesive.

The products include MAC Two-Lumen Central Venous Access Kits, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheters, Radial Artery Catheterization Kits, Percutaneous Sheath Introducers, Flextip Plus Epidural Catheters, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kits, Arrow Echogenic Introducer Needles, and Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits.

The recall began March 11, 2026, and was added to the FDA's Enforcement Report on April 22, 2026. The products were distributed in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Product details

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

    UDI-DI
    • 10801902159127
    Lot code
    • 33F25K0130

  2. Product details

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

    UDI-DI
    • 10801902206807
    Lot code
    • 33F25M0670

  3. Product details

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology

    UDI-DI
    • 10801902133110
    • 10801902223675
    • 10801902223668
    • 10801902223699
    Affected units
    33F25L0140, ASK-45703-MGH, 33F25L0143, ASK-42854-MGH, 33F25L0144, ASK-45854-MGH, 33F25L0145

  4. Product details

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

    UDI-DI
    • 10801902159127
    • 10801902213379
    • 10801902212099
    • 10801902117769
    Affected units
    33F25J0352, ASK-04020-EUH2, 33F25J0869, ASK-04020-FMC, 33F25J0870, ASK-04020-MMC, 33F25J0880

  5. Product details

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit

    UDI-DI
    • 10801902209853
    Lot code
    • 33F25K0409

  6. Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    UDI-DI
    • 10801902159578
    • 10801902223675
    • 10801902223668
    • 10801902223699
    Affected units
    33F25M0011, ASK-45703-MGH, 33F25L0143, ASK-42854-MGH, 33F25L0144, ASK-45854-MGH, 33F25L0145

  7. Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device

    Reason: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

    UDI-DI
    • 10801902220315
    Lot code
    • 33F25J0347

  8. Product details

    Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology

    UDI-DI
    • 10801902218930
    Lot code
    • 33F25M0671

Recall details

Company began the recall
Sold in

U.S. Nationwide distribution in the states of Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia.

Company
ARROW INTERNATIONAL, LLCMorrisville, North Carolina
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98618
Recall numbers
Z-1910-2026 to Z-1917-2026

All recalls from ARROW INTERNATIONAL, LLC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 10, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)