Device product
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Z-1875-2021
Product summary
- Event
- Event 87915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 tubing packs
- Official record key
device-enforcement:Z-1875-2021
Official wording
Reason: Specific lots may have been manufactured with insufficient or incomplete welds.
Code information: GTIN 00643169981102, Lot numbers 220866430, Use By 2022-04-03; 221102361, Use By 2202-04-03; and 221727287, Use By 2022-09-29.
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.