FDAClass II · Medical device · Recalled April 29, 2026

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

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1911-2026
Brand: ARROW INTERNATIONAL
Classification: Class II
Units affected: 675
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code

Companies & origin

Recalling firm location: Morrisville, NC, United States
Firm address: 3015 Carrington Mill Blvd, N/A, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots: 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
Distribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Firm notified the public via: Letter
FDA event ID: 98618
Recall initiated: March 11, 2026
FDA classified: April 22, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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