FDAFDA · Food and drugs·Recall number Z-0850-2014
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.
Published February 5, 2014 · Recall initiated: October 29, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kimberly-Clark Corporation
- Distributor
- US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
- Lot
- Lot M3085K301 and M2327K301
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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