Device product
ACS Cath Lab Pack
Z-1040-2022
Product summary
- Event
- Event 89868
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 packs
- Official record key
device-enforcement:Z-1040-2022
Official wording
Reason: Product was sterilized with a higher than specification EO concentration.
Code information: Model FTCL83K, Lot 982221 UDI: 00191072151360
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.