Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22… recallZ-0850-2014 · Kimberly-Clark Corporation · initiated Oct 29, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kimberly-Clark Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
FDA root cause category: Employee error
What the company is doing
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 the attached Product Recall Response Form-Customers via fax to: 1-920-225-4182 within five (5) business days of receipt of this letter (complete and return form even if either of the impacted product lots is NOT present in your facility). Once response form is received, a Kimberly-Clark representative will contact you regarding return and replacement of the product. If you require further assistance, please call Kimberly-Clark Customer Service at 800-KC-HELPS (800-524-3577).
Recall details
- Recall number
- Z-0850-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 29, 2013
- Posted by the FDA
- Jan 28, 2014
- Recalling firm
- Kimberly-Clark Corporation
- Quantity
- 55 cases (10 units per case = 550 units)
- Product code
- GXI
- FDA submissions
- K972846
- Distribution
- US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
Product description
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.
Code information (models, lots, serial numbers)
Lot M3085K301 and M2327K301
Other devices under the same FDA submission
4 devices cleared under K972846 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RadiOpaque Radiofrequency Cannula PMF21-100-5Avanos Medical, Inc. · Probe, radiofrequency lesion3 reports
- RadiOpaque Radiofrequency Cannula PMF20-100-10CSAvanos Medical, Inc. · Probe, radiofrequency lesion2 reports
- RadiOpaque Radiofrequency Cannula PMF22-100-10CSAvanos Medical, Inc. · Probe, radiofrequency lesion2 reports
- Radiofrequency Cannulae PMF22-100-5Avanos Medical, Inc. · Probe, radiofrequency lesion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page