Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause 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: This is an FDA Class II recall for a sterile medical device with a potential sterile barrier defect that could lead to infection. No illnesses or injuries have been reported. Under the severity rubric, this qualifies as a high-severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vygon U.S.A. is recalling the Vygon Dressing Change w/ Maxiswab (Product Code: AMS-8465CS), a custom dressing change kit. A total of 8,320 units have been distributed in Pennsylvania. The product is being recalled because the Tyvek lid may not properly adhere to the tray, which can compromise the sterile barrier and potentially cause infection.
The affected lot is Lot Number 203373129, with an expiration date of June 30, 2022.
Those with this product should contact Vygon U.S.A. for recall information and instructions.
The recalled product
- Product
- Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
- Manufacturer
- Vygon U.S.A.
- Affected units
- 8,320
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 (2)
- Lot Number: 203373129 Exp. Date: June 30
- 2022
Distribution
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