VYGON Dressing Change Kit Recalled for Potential Seal Integrity Issues
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.
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 a Class II medical device recall with potential seal integrity issues that could compromise product sterility. No illnesses, injuries, or deaths have been reported, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits (Part Number AMS-8465CS) distributed in Pennsylvania. The recall affects 520 units with Lot Number 220614962 and an expiration date of April 30, 2023.
The FDA-issued Class II recall is due to potential for incomplete seals on the dressing change kits. Incomplete seals could compromise the sterile barrier of the product.
Healthcare facilities and practitioners who received these kits should stop using affected lot and verify proper seal integrity before patient use. Consumers with questions should contact Stradis Healthcare for further guidance.
The recalled product
- Product
- VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- Manufacturer
- Stradis Healthcare
- Hazard
- Affected units
- 520
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 (4)
- Part Number AMS-8465CS
- UDI/DI: 00849884005622
- Lot Number: 220614962
- Expiration Date: 04/30/2023
Distribution
Distributed in 1 state:
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