Z-0850-2014Class II

Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in...

Name: Z-0850-2014 Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in...
Creator: Kimberly-Clark Corporation
Published: 2013-10-29
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2013-10-29 / Terminated / root cause: manufacturing process

FDA source

Kimberly-Clark Corporation began a recall of 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... on 2013-10-29. FDA classified it as Class II and gives the reason as "Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0850-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-29
Posted: 2014-01-28
Terminated: 2014-09-03
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.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot M3085K301 and M2327K301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0850-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0850-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code GXI

K972846Class IIBmc RF CannulaBaylis Medical Co., Inc. / cleared 1998-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)