Device product
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Z-1882-2021
Product summary
- Event
- Event 87915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 tubing packs
- Official record key
device-enforcement:Z-1882-2021
Official wording
Reason: Specific lots may have been manufactured with insufficient or incomplete welds.
Code information: GTIN 00763000341015, Lot numbers 221102372, Use By 2022-09-21; and 221672013, Use By 2022-11-02
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.
Derived failure modes
-
Unknown
Specific lots may have been manufactured with insufficient or incomplete welds.