FDA recall Z-1406-2025

American Contract Systems Inc · Class II · device

Product

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

Reason for recall

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

Distribution

US: MI

Key facts

Status: Ongoing
Initiation date: 2025-02-04
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tiffin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2025