Z-0850-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2014
- Initiation Date
- October 29, 2013
- Termination Date
- September 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Lot M3085K301 and M2327K301