FDA-Device2022-09-14Class II

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

Stradis Healthcare
Hazard

Potential for incomplete seals.

Sold states
Pennsylvania
Affected count
520 units
Manufactured in
3600 Burwood Dr, N/A, Waukegan, IL, United States
Products
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1688-2022

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