Medical device recalls Moderate risk

ARROW INTERNATIONAL, LLC recalls PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)2…

Recall date
March 11, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1912-2026
FDA classification
Class II
Brand / firm
ARROW INTERNATIONAL, LLC
Sold / distributed
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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