Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Recall
- Recall Number
- Z-0623-2024
- Event Number
- 93558
- Firm
- Medtronic Inc.
- FEI Number
- 2183870
- Product Code
- NIP
- Status
- Completed
- Root Cause
- Packaging change control
- Initiated
- November 20, 2023
- Posted
- January 2, 2024
- Address
- 4600 Nathan Ln N, Plymouth, MN, 55442-2890
Description
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Seal defects could compromise the ability of the product packaging to maintain sterility.
On 11/17/2023, Medtronic emailed an Immediate Action Communication to their field representative to guide them in speaking with their sole consignee facility. The communication provided the details of the product and the reason for recall. The field representative was to notify the consignee facility and ask them to quarantine the product. The representative was to notify the recalling firm of the name, title and phone number of the person contacted at the facility, the date and method they were notified, include any additional questions the customer has in the short-term, and advise if the customer will be quarantining the device. The consignee facility was verbally notified via telephone on 11/20/2023. An Urgent Medical Device Recall letter dated November 2023 for the attention of the Risk Manager was enclosed, which was hand-delivered to the facility on 12/1/2023. The consignee is asked to identify, segregate, quarantine and return any affected product they may have in their inventory and complete and return the Customer Acknowledgement Form.
US Nationwide distribution in the state of MN.
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