FDA recall Z-1702-2022

American Contract Systems, Inc. · Class II · device

Product

Various hysterectomy, vaginal packs

Reason for recall

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Distribution

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Key facts

Status
Ongoing
Initiation date
2022-06-16
Report date
2022-09-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2022