Z-0137-2025 Class II Ongoing
FDA device recall Z-0137-2025 was initiated by Medtronic Neuromodulation on September 11, 2024 and is designated Class II. Reason for recall: Potential for error and inability to interrogate pump due to data corruption in the pump memory. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason for Recall
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Distribution Pattern
US Nationwide distribution in the state of Mississippi.
Code Information
GTIN Number: 00643169630505. Serial Number: NGP004814H