FDA recall Z-1040-2022
American Contract Systems, Inc. · Class II · device
Product
ACS Cath Lab Pack
Reason for recall
Product was sterilized with a higher than specification EO concentration.
Distribution
US Nationwide distribution in the states of IL, MO, NE, and TX.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-03-22
- Report date
- 2022-05-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kansas City, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2022