PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 25, 2020 Initiated: February 18, 2020 #Z-1522-2020

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.

Details

Recalling Firm
Avid Medical, Inc.
Units Affected
2,632 each
Distribution
US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Location
Toano, VA

Frequently Asked Questions

What product 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.. Recalled by Avid Medical, Inc.. Units affected: 2,632 each.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1522-2020.