Home / Recalls / Medical Devices
American Contract Systems recalls Sterile Custom Packs to be used in surgical procedures.
Recalled June 10, 2020 · FDA recall Z-2173-2020 · American Contract Systems
Hazard
The surgical gowns were manufactured in a facility that is not registered by the FDA. · FDA Class II
Units
2868 total kits
Sold at
US Nationwide distribution including in the state of Pennsylvania.
Description
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Product
Sterile Custom Packs to be used in surgical procedures.
Manufacturer(s)
American Contract Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →