Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Ord...

FDA Device Recall #Z-1786-2025 — Class II — April 17, 2025

Recall Summary

Recall Number Z-1786-2025
Classification Class II — Moderate risk
Date Initiated April 17, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Incorporated
Location Bloomington, IN
Product Type Devices
Quantity 99 units

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.

Distribution Pattern

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

Lot / Code Information

UDI/DI 00827002086869, Lot Number 16376248

Other Recalls from Cook Incorporated

Recall # Classification Product Date
Z-1934-2026 Class I Centimeter Sizing Catheter RPN N5.0-35-100-P-1... Apr 2, 2026
Z-1935-2026 Class I Aurous Centimeter Sizing Catheter RPN N5.0-35-... Apr 2, 2026
Z-1936-2026 Class I Beacon Tip Centimeter Sizing Catheter RPN/GPN ... Apr 2, 2026
Z-1784-2026 Class II COOK MEDICAL Cook¿ Strange Bile Duct Stone Expl... Mar 5, 2026
Z-1780-2026 Class II COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous ... Mar 5, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.