Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical, Inc. is recalling 1,906 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of surgical site infection and cross-contamination from potentially non-sterile components, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Avid Medical, Inc. is recalling 1,906 custom procedure trays containing medical components used for minor and major patient surgeries. The recall is due to the inclusion of surgical gowns that were manufactured at locations that did not maintain proper environmental conditions. Consequently, there is no assurance that these gowns are sterile.
An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Additionally, 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.
The affected trays were distributed in Arizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Wisconsin, and Virginia. Healthcare facilities should stop using these trays and contact Avid Medical, Inc. for instructions on return or disposal.
The recalled product
- 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.
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Trays
- Affected units
- 1,906
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Item Codes:ADVC033-16
- ADVG034-15
- ADVU018-24
- JNTH001-04
- JNTH001-05
- JNTH002-05
- SHER019-07
- YAVA100-05. Lot Numbers: 1344066
- 1344358
- 1353858
- 1353860
- 1354012
- 1359439
- 1361116
- 1361767
- 1363232
- 1365746
- 1379393. Expiration dates: 2/28/21 thru 7/30/2022.
Distribution
Part of a larger recall action
This product is one of 9 recalled by Avid Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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