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Recall Observatory FDA recall evidence

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

February 18, 2020

Class II

Product summary

Firm
Avid Medical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.