Recall Z-0850-2014— Kimberly-Clark Corporation
Class II · Terminated
Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2013-10-29, terminated 2014-09-03. It names one FDA 510(k) clearance: K972846. 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.. Reason: Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-29
- Terminated
- 2014-09-03
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.