Cook Incorporated 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Cook Incorporated
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT due to Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026