Recall Z-1755-2010 ยท GXI Probe, Radiofrequency Lesion
Baylis Medical Corp *
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 les
| Date | Jun 3, 2010 (initiated May 12, 2010) |
| Status | Terminated |
| Reason | Name of the device reflected on the product packing sleeve is incorrect. |
| 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 Lumbar |
| Quantity | 58 |
| Distribution | Nationwide distribution: TX |
| FDA record | Open on fda.gov |