Cook Incorporated Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Brand
Cook Incorporated
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
TCMTNA-35-145-3 G01678 UDI-DI: 00827002016781 Lots/Expiration Dates: 14808819 22-06-2027 NS14821223 30-06-2027 NS14851713 21-07-2027
Cook Incorporated is recalling Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-1 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