Thirty-five recall
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1)…
Why was Thirty-five recalled?
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 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?
Part number M365SC3138350; serial numbers 1041034, 1055172, 3000549, 1041380, 1056806, 3000564, 1053375, 1058008, 3001907, 1053695, 1058015, 3007457, 1053700, 1058017, 3008119, 1054299, 1062660, 1054304, and 1064590.
- Product
- Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1)…
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Quantity
- 19 units
- Distribution
- Distributed OUS only. to 14 countries.
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)