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Home › FDA recalls › PERCUTANEOUS SHEATH INTRODUCER with 7.5
CLASS II · ModerateFDA

ARROW INTERNATIONAL, LLC recalls PERCUTANEOUS SHEATH INTRODUCER with 7.5

📅 Mar 11, 2026 · 📍 Nationwide
Recalling company
ARROW INTERNATIONAL, LLC
Product
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.
Reason
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 11, 2026
Reported
Apr 29, 2026
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Status
Ongoing
Quantity
115
Lot / codes
Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130
Company location
Morrisville, NC
Recall type
Voluntary: Firm initiated
Recall number
Z-1912-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1912-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.