Z-1521-2020 Class II Terminated
FDA device recall Z-1521-2020 was initiated by Avid Medical, Inc. on February 18, 2020 and is designated Class II. 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… The recall status is terminated (terminated November 23, 2020). Affected quantity: 628.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 18, 2020
- Termination Date
- November 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 628
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.
Distribution Pattern
US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Code Information
Item Codes: ADCO026-17, SINA217. Lot Numbers: 1336261, 1361099, 1363225, 1367696, 1371095, 1374420, 1376394, 1383159. Expiration dates: 02/10/2020-11/18/2022.