FDA recall Z-1787-2025

Cook Incorporated · Class II · device

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 for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

Key facts

Status: Ongoing
Initiation date: 2025-04-17
Report date: 2025-05-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1787-2025