Avid Medical, Inc. recalls Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and m…

Recall date

February 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1521-2020

FDA classification

Class II

Brand / firm

Avid Medical, Inc.

Sold / distributed

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.