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Recall Observatory FDA recall evidence

Device product

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.

Z-1911-2026

March 11, 2026

Class II

Product summary

Firm
ARROW INTERNATIONAL, LLC
Event
Event 98618
Status
Ongoing
Classification
Class II
Quantity
675
Official record key
device-enforcement:Z-1911-2026

Official wording

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

Code information: 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 pattern: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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