Device product
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Z-1883-2021
Product summary
- Event
- Event 87915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 tubing packs
- Official record key
device-enforcement:Z-1883-2021
Official wording
Reason: Specific lots may have been manufactured with insufficient or incomplete welds.
Code information: GTIN 00763000467449, Lot number 221227814, Use By 2022-08-28
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.