Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Reported: January 10, 2024 Initiated: November 20, 2023 #Z-0623-2024
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.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- 1
- Distribution
- US Nationwide distribution in the state of MN.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.. Recalled by Medtronic Inc.. Units affected: 1.
Why was this product recalled? ▼
Seal defects could compromise the ability of the product packaging to maintain sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2024. Severity: Moderate. Recall number: Z-0623-2024.
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