FDA-Device2020-03-25Class II
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
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.
Sold states
US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Affected count
628
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1521-2020More Avid Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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