FDA Enforcement
Class II
Completed
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Recall: Z-0623-2024
·
Reported January 10, 2024
Enforcement
- Recall Number
- Z-0623-2024
- Event ID
- 93558
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Medtronic Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- January 10, 2024
- Initiation Date
- November 20, 2023
- Classification Date
- January 2, 2024
- Address
- 4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States
Description
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Reason
Seal defects could compromise the ability of the product packaging to maintain sterility.
Code Info
Lot number B644679, UDI-DI 00643169728974.
Distribution
US Nationwide distribution in the state of MN.
Quantity
1