[Recalled] Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. — The medical procedure trays contain one or more recal
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Avid Medical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1522-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 February 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.