Recall Z-1520-2020— Avid Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Avid Medical, Inc., initiated 2020-02-18, terminated 2020-11-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Avid Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-18
- Terminated
- 2020-11-23
- Firm location
- Toano, VA, United States
Product description
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.