FDA recall Z-1688-2022
Stradis Healthcare · Class II · device
Product
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Reason for recall
Potential for incomplete seals.
Distribution
Pennsylvania
Key facts
- Status
- Ongoing
- Initiation date
- 2022-05-10
- Report date
- 2022-09-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1688-2022