Device 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.
Z-1517-2020
Product summary
- Event
- Event 85049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,644 each
- Official record key
device-enforcement:Z-1517-2020
Official wording
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.
Code information: Item Codes: ADBR043-08, ADCO001-20, ADCO001-20, ADCO002-15, ADCO005-29, ADCO007-21, ADVC015-23, ADVC032-21, ADVC046-12, ADVH073-13, ADVM040-07, ADVM050-02, SHER020-10, SINA223, VAHT026-07, YAVA115-04, YAVA130, YAVA131-03. Lot numbers: 1333107, 1333471, 1336767, 1337370, 1339098, 1339331, 1342016, 1347760, 1347896, 1348407, 1353068, 1353419, 1354811, 1357043, 1359839, 1360420, 1361445, 1363245, 1365971, 1367018, 1367137, 1367218, 1367987, 1368726, 1369130, 1370525, 1370700, 1370929, 1371222, 1372022, 1372310, 1372407, 1373347, 1374864, 1375307, 1375787, 1376196, 1376397, 1378227, 1380392, 1380874, 1381757, 1382980, 1383533, 1384526, 1385192. Expiration Dates: 9/30/2020-10/17/2022
Distribution pattern: US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Derived failure modes
-
Unknown
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.