Custom procedure trays containing medical components recall: Contamination
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries.…
Why was Custom procedure trays containing medical components recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Codes: ADVC065-18, ADVC068-21, ADVH078-17, ADVM042-07. Lot Numbers: 1324410, 1344158, 1356561, 1366768, 1372012, 1373518, 1375096, 1377349, 1378072, 1378073, 1379861, 1381271, 1381272. Expiration dates: 05/01/2020-09/30/2021.
- Product
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries.…
- Recalling firm
- Avid Medical, Inc.
- Quantity
- 400 each
- Distribution
- US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)