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

FDA Device Recall #Z-0850-2014 — Class II — October 29, 2013

Recall Summary

Recall Number Z-0850-2014
Classification Class II — Moderate risk
Date Initiated October 29, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Kimberly-Clark Corporation
Location Roswell, GA
Product Type Devices
Quantity 55 cases (10 units per case = 550 units)

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.

Reason for Recall

Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

Distribution Pattern

US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.

Lot / Code Information

Lot M3085K301 and M2327K301

Other Recalls from Kimberly-Clark Corporation

Recall # Classification Product Date
Z-0748-2019 Class II U by Kotex¿ Sleek¿, Regular Tampons, 18 Count Dec 11, 2018
Z-0749-2019 Class II U by Kotex¿ Sleek¿, Regular Tampons, 34 Count Dec 11, 2018
Z-0750-2019 Class II U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 C... Dec 11, 2018
Z-0751-2019 Class II U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Dec 11, 2018
Z-0518-2014 Class II Kimberly-Clark Single Shot Epidural Pain Manage... Oct 24, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.