Recall Z-1787-2025— Cook Incorporated

Name: FDA recall Z-1787-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2025-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,. Reason: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2025-04-17
Firm location: Bloomington, IN, United States

Product description

Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

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