FDA Enforcement
Class II
Ongoing
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
Recall: Z-1838-2022
·
Reported October 5, 2022
Enforcement
- Recall Number
- Z-1838-2022
- Event ID
- 90793
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 5, 2022
- Initiation Date
- August 16, 2022
- Classification Date
- September 28, 2022
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
Description
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
Reason
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Code Info
RFSPC-35-145 G09607 UDI-DI: 00827002096073 Lot/Expiration Date: 14831437 07-07-2025 14831438 07-07-2025 14835040 11-07-2025 14840287 13-07-2025 14840288 13-07-2025 14840309 13-07-2025
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Quantity
277 US; 138 OUS