Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
- Company
- Cook Incorporated
- Recall Initiated
- August 16, 2022
- Posted
- September 28, 2022
- Recall Number
- Z-1846-2022
- Quantity
- No distribution (Distribution Center only)
- 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
TCMTNA-35-145-3 G01678 UDI-DI: 00827002016781 Lots/Expiration Dates: 14808819 22-06-2027 NS14821223 30-06-2027 NS14851713 21-07-2027
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