FDA Device recall Z-1519-2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri… by Avid Medical, citing 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 n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1519-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-18 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Avid Medical |
| Distribution | AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX, VA, WI |
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.
Identifiers
| code_info | Item Codes: SHER010-12. Lot Numbers: 1339900, 1352089, 1361835, 1370391, 1372029. Expiration dates: 12/15/2020-09/05/2021. , |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1519-2020%22
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