VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS recallZ-1688-2022 · Stradis Healthcare · initiated May 10, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stradis Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for incomplete seals.
FDA root cause category: Other
What the company is doing
Stradis notified its sole consignee initially by telephone on 05/10/2022 and followed with a letter disseminated by email on 05/11/2022. The letter explained the problem, risk to health, and requested the quarantine of the affected product pending return. The letter directed the consignee to notify their customers to whom they further distributed the product to return the product to Stradis.
Recall details
- Recall number
- Z-1688-2022
- Status
- Open, Classified
- Initiated by the company
- May 10, 2022
- Recalling firm
- Stradis Healthcare
- Quantity
- 520 units
- Product code
- OXQ
- Distribution
- Pennsylvania
Product description
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Code information (models, lots, serial numbers)
Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VYGON AMS-8465CSVygon Corporation · Dressing change tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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