Z-1847-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
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 Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
TMT-35-145 G01677 UDI-DI: 00827002016774 Lot/Expiration Date: 14808818 22-06-2027