FDA recall Z-1335-2025

American Contract Systems Inc · Class II · device

Product

CYSTO PACK , Model N. HKCY31A

Reason for recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Distribution

US Nationwide distribution in the state of OH.

Key facts

Status: Ongoing
Initiation date: 2025-02-06
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-1335-2025