FDAFDA · Food and drugs·Recall number Z-2125-2020
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication.
Published June 3, 2020 · Recall initiated: April 24, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Distributor
- Distributed OUS only. to 14 countries.
- Lot
- Part number M365NM3138550; serial numbers 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225 and 3012324.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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