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U.S. Department of Health and Human Services

Class 2 Device Recall KimberlyClark RadiOpaque Radiofrequency Cannula

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  Class 2 Device Recall KimberlyClark RadiOpaque Radiofrequency Cannula see related information
Date Initiated by Firm October 29, 2013
Date Posted January 28, 2014
Recall Status1 Terminated 3 on September 03, 2014
Recall Number Z-0850-2014
Recall Event ID 66832
510(K)Number K972846  
Product Classification Probe, radiofrequency lesion - Product Code GXI
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.
Code Information Lot M3085K301 and M2327K301
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076-2190
For Additional Information Contact Thomas Kozma, PhD
770-587-8393
Manufacturer Reason
for Recall		 Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = BAYLIS MEDICAL CO., INC.
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