Protege GPS Self-Expanding Peripheral Stent System recall: Sterility Concern
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Why was Protege GPS Self-Expanding Peripheral Stent System recalled?
Seal defects could compromise the ability of the product packaging to maintain sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number B644679, UDI-DI 00643169728974.
- Product
- Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
- Recalling firm
- Medtronic Inc.
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of MN.
- Recall date
- January 10, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)