Avid Medical Recalls Custom Procedure Trays with Non-Sterile Gowns
Avid Medical is recalling 400 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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-harm product (non-sterile surgical gowns) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of surgical site infection.
Plain-English summary
Avid Medical, Inc. is recalling 400 custom procedure trays that contain medical components for minor and major surgeries. The recall is necessary because the trays contain one or more 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 products include item codes ADVC065-18, ADVC068-21, ADVH078-17, and ADVM042-07, with lot numbers ranging from 1324410 to 1381272. Expiration dates range from 05/01/2020 to 09/30/2021. The products 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 for instructions.
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.
- Affected units
- 400
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 (16)
- 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.
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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