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U.S. Department of Health and Human Services

Class 2 Device Recall Baylis Medical LumbarCool Pain Management System

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 Class 2 Device Recall Baylis Medical LumbarCool Pain Management Systemsee related information
Date Initiated by FirmMay 12, 2010
Date PostedJune 03, 2010
Recall Status1 Terminated 3 on October 04, 2010
Recall NumberZ-1755-2010
Recall Event ID 55693
510(K)NumberK053082 K062937 
Product Classification probe, radiofrequency lesion - Product Code GXI
ProductThe 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 Lot Number: LKFA160310
Recalling Firm/
Manufacturer		 Baylis Medical Corp *
5959 Trans-Canada Hwy
Montreal Canada
For Additional Information ContactCUSTOMER SERVICE
800-850-9801
Manufacturer Reason
for Recall		Name of the device reflected on the product packing sleeve is incorrect.
FDA Determined
Cause 2		Error in labeling
ActionThe 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 Commerce58
DistributionNationwide distribution: TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GXI
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