The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Managemen
FDA device recall Z-1755-2010 · posted 2010-06-03 · Terminated
Recall details
- Recalling firm
- Baylis Medical Corp *
- Reason for recall
- Name of the device reflected on the product packing sleeve is incorrect.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GXI
- Quantity affected
- 58
- Distribution
- Nationwide distribution: TX
- Date initiated
- 2010-05-12
- Date posted
- 2010-06-03
- Date terminated
- 2010-10-04
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU (K062937) | Baylis Medical Co., Inc. | 2007-01-08 |
| BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 (K053082) | Baylis Medical Co., Inc. | 2005-11-30 |