FDAFDA · Food and drugs·Recall number Z-0623-2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Published January 10, 2024 · Recall initiated: November 20, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Seal defects could compromise the ability of the product packaging to maintain sterility.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- US Nationwide distribution in the state of MN.
- Lot
- Lot number B644679, UDI-DI 00643169728974.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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