FDAClass IISeptember 14, 2022

Vygon Dressing Change W/maxiswab Kit recall

VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

Why was Vygon Dressing Change W/maxiswab Kit recalled?

Potential for incomplete seals.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023

Product
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Recalling firm
Stradis Healthcare
Quantity
520 units
Distribution
Pennsylvania
Recall date
September 14, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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