Recall Z-1519-2020 ยท OGJ Nerve Block Tray
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
| Date | Feb 18, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | URGENT MEDICAL DEVICE RECALL NOTICE letters, dated February 18, 2020, were distributed to customers. Letter provides identification of the issue, health risk and action to take. Customers were instructed to take the following required actions: " Review all storage and usage locations and segregate and quarantine any trays with an item code and lot number listed on attached Exhibit A. " Complete and return the enclosed Recall Response Form to Sharon.moll@owens-minor .com. Please respond even if you do not have any trays subject to this recall. " Upon receipt of your completed Recall Response |
| Quantity | 230 each |
| Distribution | US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.