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American Contract Systems recalls Sterile Custom Packs to be used in surgical procedures.
Recalled June 10, 2020 · FDA recall Z-2177-2020 · American Contract Systems
Hazard
The surgical gowns were manufactured in a facility that is not registered by the FDA. · FDA Class II
Units
2,8,68 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 →