Device product
ACS IR - Angio Pack
Z-1038-2022
Product summary
- Event
- Event 89868
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 packs
- Official record key
device-enforcement:Z-1038-2022
Official wording
Reason: Product was sterilized with a higher than specification EO concentration.
Code information: Model JEIR37H, Lot 657211 UDI: 00191072151612
Distribution pattern: US Nationwide distribution in the states of IL, MO, NE, and TX.
Derived failure modes
-
Unknown
Product was sterilized with a higher than specification EO concentration.