Z-0623-2024 Class II
FDA device recall Z-0623-2024 was initiated by Medtronic Inc. on November 20, 2023 and is designated Class II. Reason for recall: Seal defects could compromise the ability of the product packaging to maintain sterility. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- November 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Reason for Recall
Seal defects could compromise the ability of the product packaging to maintain sterility.
Distribution Pattern
US Nationwide distribution in the state of MN.
Code Information
Lot number B644679, UDI-DI 00643169728974.