Z-1688-2022 Class II Ongoing
FDA device recall Z-1688-2022 was initiated by Stradis Healthcare on May 10, 2022 and is designated Class II. Reason for recall: Potential for incomplete seals. The recall status is ongoing. Affected quantity: 520 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- May 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 520 units
Product Description
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Reason for Recall
Potential for incomplete seals.
Distribution Pattern
Pennsylvania
Code Information
Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023