Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
- Company
- Cook Incorporated
- Recall Initiated
- August 16, 2022
- Posted
- September 28, 2022
- Recall Number
- Z-1839-2022
- Quantity
- 202 US; 11 OUS
- Firm Location
- Bloomington, IN
Reason for Recall
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.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Lot / Code Info
RFPC-35-145 G07914 UDI-DI: 00827002079144 Lots/Expiration Date: 14828624 06-07-2025 14828638 06-07-2025 14837046 12-07-2025 NS14828650 06-07-2025
Root Cause
Under Investigation by firm
Action Taken
On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235