Recall Z-1912-2026— ARROW INTERNATIONAL, LLC

Name: FDA recall Z-1912-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-11

Class II · Ongoing

Class II FDA medical device recall by ARROW INTERNATIONAL, LLC, initiated 2026-03-11. FDA's recall record names no specific 510(k) clearance for this event. 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.

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-11
Firm location: Morrisville, NC, United States

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.