Reported Apr 29, 2026 · Ongoing

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code:…

Arrow International, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ARROW INTERNATIONAL, LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

  • 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
Lot codes and dates
  • Product codeASK-09903-MGH3
  • UDI code(01)10801902159127(17)270331(11)251203(10)33F25J0352
  • Batch Number33F25K0130
Amount recalled
115

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.