Recall Z-0850-2014 ยท GXI Probe, Radiofrequency Lesion
Kimberly-Clark Corporation
Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
| Date | Jan 28, 2014 (initiated Oct 29, 2013) |
| Status | Terminated |
| Reason | Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label. |
| Root cause | Employee error |
| Action | The firm, Kimberly-Clark Corporation, sent an "URGENT: Voluntary Medical Device Recall Notification" letter dated October 29, 2013 to all direct customers and distributors via federal express priority overnight. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate your Facility's inventory of Kimberly-Clark RadiOpaque Radiofrequency Cannula to determine if any of the two impacted product lots remain within your facility. If product is present, discontinue use of the impacted product and place in a quarantined location; complete and return |
| Quantity | 55 cases (10 units per case = 550 units) |
| Distribution | US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972846 | BMC RF CANNULA Baylis Medical Co., Inc., Jul 17, 1998 |