Z-1892-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 29, 2021
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 tubing packs
Product Description
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Reason for Recall
Specific lots may have been manufactured with insufficient or incomplete welds.
Distribution Pattern
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Code Information
GTIN 00763000458133, Lot number 221249911, Use By 2022-10-22