The Baylis LumbarCool Pain Management Kit consisting of: 1… recallZ-1755-2010 · Baylis Medical Corp * · initiated May 12, 2010
Terminated All recalls posted in June 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baylis Medical Corp * or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Name of the device reflected on the product packing sleeve is incorrect.
FDA root cause category: Error in labeling
What the company is doing
The firm, Baylis Medical, notified US Distributor by email and sent a "URGENT Field Corrective Action Notice" dated May 12, 2010, to customer. The notifications described the product, problem and action to be taken by customer. The customers were given the follow options: Option 1: In order to prevent confusion in identification of the product before use, please immediately remove and dispose the package sleeve that covers the tray packaging of the LumbarCool Pain Management Kit. Option 2: Alternatively, you may exchange your kit from Lot LKFA160310 with a correctly labeled replacement LumbarCool Pain Management Kit by contacting Kimberly-Clark Health Care sales representative. The customers were ask to fill out the Field Corrective Action Acknowledgment and return it. Any question please call Baylis Sales Representative at 905-602-4875 and/or contact your local sales representative for any further information you may require.
Recall details
- Recall number
- Z-1755-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 12, 2010
- Posted by the FDA
- Jun 3, 2010
- Recalling firm
- Baylis Medical Corp *
- Quantity
- 58
- Product code
- GXI
- FDA submissions
- K053082, K062937
- Distribution
- Nationwide distribution: TX
Product description
The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.
Code information (models, lots, serial numbers)
Lot Number: LKFA160310
Other devices under the same FDA submission
3 devices cleared under K053082, K062937 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AVANOS CRK-17-50-4Avanos Medical, Inc. · Probe, radiofrequency lesion3 reports
- AVANOS CRK-17-150-4Avanos Medical, Inc. · Probe, radiofrequency lesion1 report
- Halyard 44075Avanos Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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