Z-1755-2010

The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool...

Name: Z-1755-2010 The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool...
Creator: Baylis Medical Corp *
Published: 2010-05-12
License: https://open.fda.gov/license/

Baylis Medical Co., Inc. / initiated 2010-05-12 / Terminated / root cause: labeling and UDI

FDA source

Baylis Medical Corp * began a recall of The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management... on 2010-05-12. The reason FDA records is "Name of the device reflected on the product packing sleeve is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1755-2010
Status: Terminated
Initiated: 2010-05-12
Posted: 2010-06-03
Terminated: 2010-10-04
Recalling firm: Baylis Medical Co., Inc.
Product: 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.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Name of the device reflected on the product packing sleeve is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 58
Distribution: Nationwide distribution: TX
Product codes and lots: Lot Number: LKFA160310

Product code GXI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)