Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
This recall is currently active, issued September 28, 2022. It was issued by Cook Incorporated.
- Company
- Cook Incorporated
- Recall Initiated
- August 16, 2022
- Posted
- September 28, 2022
- Recall Number
- Z-1829-2022
- Quantity
- 1,501 US; 380 OUS
- Firm Location
- Bloomington, IN
- Official Source
- View on FDA website ↗
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
PMG-18SP-60-COPE-NT-ST G09395 UDI-DI: 00827002093959 Lot/Expiration Date 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027 PMG-18SP-100-COPE-NT G08687 UDI-DI: 00827002086876 Lot/Expiration Date 14811839 24-06-2027 14839563 13-07-2027 PMG-18SP-60-COPE-NT G08427 UDI-DI: 00827002084278 Lot/Expiration Date 14816750 28-06-2027 14816753 28-06-2027 14816754 28-06-2027 14816755 28-06-2027 14816757 28-06-2027 14821755 30-06-2027 14821756 30-06-2027 14821758 30-06-2027 14831332 07-07-2027 14831333 07-07-2027 14831335 07-07-2027 14831336 07-07-2027 NS14813725 27-06-2027 NS14816751 28-06-2027 NS14821760 30-06-2027 NS14828069 05-07-2027 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027
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