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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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