FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0850-2014
- Recalling firm
- Kimberly-Clark Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-10-29
- Posted
- 2014-01-28
- Terminated
- 2014-09-03
- 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 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).
- 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.
- Lot, serial or model codes
- Lot M3085K301 and M2327K301
- 510(k) numbers
- ["K972846"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 1000015879
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28