Device product
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Z-1876-2021
Product summary
- Event
- Event 87915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 tubing packs
- Official record key
device-enforcement:Z-1876-2021
Official wording
Reason: Specific lots may have been manufactured with insufficient or incomplete welds.
Code information: GTIN 00643169641228, Lot numbers 220866440, Use By 2022-07-10; and 221451579, Use By 2022-10-24
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.