FDA recall Z-3237-2024

American Contract Systems, Inc. · Class II · device

Product

Hand Pack, AKHD97C; Medical convenience kit

Reason for recall

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Distribution

US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Key facts

Status
Ongoing
Initiation date
2024-08-07
Report date
2024-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3237-2024