Device product
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Z-0623-2024
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 93558
- Status
- Completed
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0623-2024
Official wording
Reason: Seal defects could compromise the ability of the product packaging to maintain sterility.
Code information: Lot number B644679, UDI-DI 00643169728974.
Distribution pattern: US Nationwide distribution in the state of MN.
Derived failure modes
-
Sterility assurance
Seal defects could compromise the ability of the product packaging to maintain sterility