Class II U.S. Food and Drug Administration

Arrow Radial Artery Catheterization KIT REF ASK-04220-UCL1 UDI code recall: Due to receiving a notice from a supplier that the liquid adhesive

Recall published 6 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1911-2026
Published
April 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Arrow International, LLC
Product type
Medical devices
Units affected
675
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
10801902159127, 10801902213379, 10801902212099, 10801902117769

Products covered by this recall

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.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10801902159127
  • 10801902213379
  • 10801902212099
  • 10801902117769

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 33F25J0880 — 675

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Arrow International, LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: ARROW INTERNATIONAL, LLC — 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Arrow International, LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10801902159127, 10801902213379, 10801902212099; lot code 33F25J0880 — 675. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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