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Recall Observatory FDA recall evidence

Device product

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

Z-1688-2022

May 10, 2022

Class II

Product summary

Firm
Stradis Healthcare
Event
Event 90693
Status
Ongoing
Classification
Class II
Quantity
520 units
Official record key
device-enforcement:Z-1688-2022

Official wording

Reason: Potential for incomplete seals.

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

Distribution pattern: Pennsylvania

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for incomplete seals.