Recall Ledger

ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: recall (ARROW INTERNATIONAL, LLC)

Medical deviceClass IIOngoing

Summary: ARROW INTERNATIONAL, LLC is recalling 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 R. Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured.

What is being recalled

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.

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. (states named: Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, Virginia)

How to tell if yours is affected

Product code:ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25J0352 Product code: ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 Batch Number: 33F25J0869 Product code: ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 Batch Number: 33F25J0870 Product code: ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 Batch Number: 33F25J0880

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1911-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMarch 11, 2026
ReportedApril 29, 2026
CompanyARROW INTERNATIONAL, LLC
Company locationMorrisville, NC, United States
Initiated byVoluntary: Firm initiated
Quantity675

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