FDA Enforcement
Class II
Ongoing
SynchroMed II Infusion Pump. Product Number: 8637-20
Recall: Z-0137-2025
·
Reported October 30, 2024
Enforcement
- Recall Number
- Z-0137-2025
- Event ID
- 95419
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Neuromodulation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- October 30, 2024
- Initiation Date
- September 11, 2024
- Classification Date
- October 21, 2024
- Address
- 7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States
Description
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Code Info
GTIN Number: 00643169630505. Serial Number: NGP004814H
Distribution
US Nationwide distribution in the state of Mississippi.
Quantity
1 unit