Recall archive / FDA device enforcement
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS — FDA record Z-1688-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 10, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- Reason
- Potential for incomplete seals.
- Classification
- Class II
- Recalling firm
- Stradis Healthcare
- Quantity
- 520 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1688-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Pennsylvania
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- May 10, 2022
- Center classification date
- Sep 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.