FDA recall Z-2522-2024

American Contract Systems, Inc. · Class II · device

Product

American Contract Systems Cataract Pack convenience kit

Reason for recall

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

Distribution

US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Key facts

Status
Ongoing
Initiation date
2024-05-06
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2024