Z-1826-2022 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
- 43 OUS
Product Description
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
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
TSMB-35-145 (GPN G27041) UDI-DI 00827002270411, Lot 14797970, Expiration Date 16-06-2027