CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report

Vygon Dressing Change W/Maxiswab kit recalled by Stradis Healthcare

Stradis Healthcare is recalling Vygon Dressing Change W/Maxiswab kit, distributed in Pennsylvania. The recall was initiated on 10 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023

Quantity recalled520 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1688-2022
FDA event ID: 90693
Recalling firm: Stradis Healthcare, Waukegan, IL
Classification: Class II
Status: Ongoing
Recall initiated: 10 May 2022
FDA classified: 8 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

10 May 2022	Recall initiated by company
8 Sep 2022	Classified by FDA	+121 days
14 Sep 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for incomplete seals.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Pennsylvania

Questions about this recall

Why was it recalled?

Potential for incomplete seals.

Which lots are affected?

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

Where was it sold?

Pennsylvania

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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