Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 230 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 surgical site infection due to potential lack of sterility, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Avid Medical, Inc. is recalling 230 custom procedure trays containing medical components used for minor and major patient surgeries. The recall is due to the presence of one or more recalled surgical gowns within the trays. These gowns were manufactured at locations that did not maintain proper environmental conditions, meaning there is no assurance that they 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, posing a risk of cross-contamination.
The affected trays are distributed in Arizona, California, Illinois, Indiana, Maryland, Mississippi, New Jersey, Nevada, New York, Tennessee, Texas, Wisconsin, and Virginia. Item codes are SHER010-12, and lot numbers include 1339900, 1352089, 1361835, 1370391, and 1372029. Expiration dates range from 12/15/2020 to 09/05/2021. Healthcare facilities should stop using these trays and contact Avid Medical 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
- 230
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 (5)
- Item Codes: SHER010-12. Lot Numbers: 1339900
- 1352089
- 1361835
- 1370391
- 1372029. Expiration dates: 12/15/2020-09/05/2021.
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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