FDA recall Z-2179-2020
American Contract Systems · Class II · device
Product
Sterile Custom Packs to be used in surgical procedures.
Reason for recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Distribution
US Nationwide distribution including in the state of Pennsylvania.
Key facts
- Status
- Terminated
- Initiation date
- 2020-04-13
- Report date
- 2020-06-10
- Termination date
- 2020-11-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Zelienople, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2020