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.
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: 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
- incomplete-seal
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
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01