Device product
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Z-1877-2021
Product summary
- Event
- Event 87915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 tubing packs
- Official record key
device-enforcement:Z-1877-2021
Official wording
Reason: Specific lots may have been manufactured with insufficient or incomplete welds.
Code information: GTIN 00763000314231, Lot numbers 220911913, Use By 2022-03-13; and 221249923, Use By 2022-10-01
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.