Class II

Medical Device Recall: Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Cook Incorporated · April 17, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

99 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1786-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.