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Avid Medical, Inc. recalls Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and ma
Recalled March 25, 2020 · FDA recall Z-1521-2020 · Avid Medical
Hazard
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination. · FDA Class II
Units
628
Sold at
US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Description
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Manufacturer(s)
Avid Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →