Recall Z-1786-2025— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2025-04-17. It names one FDA 510(k) clearance: K171999. Product: Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
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.