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U.S. Department of Health and Human Services

Class 2 Device Recall Neutralect

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  Class 2 Device Recall Neutralect see related information
Date Initiated by Firm January 22, 2010
Date Posted March 16, 2010
Recall Status1 Terminated 3 on June 10, 2010
Recall Number Z-1142-2010
Recall Event ID 54363
510(K)Number K982130  
Product Classification diathermy cables - Product Code GEI
Product Neutralect Diathermy Cable,
Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
Code Information Ref code 3508M, Ref Code 3405M, no expiration dates. Lot numbers: 568229, 568588, 568784, 569128, 620731, 621058, 621143, 621453, 621608, 622599, 622890. 
Recalling Firm/
Manufacturer		 ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558
For Additional Information Contact Barbara DeLade
908-904-2235
Manufacturer Reason
for Recall		 Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M.
FDA Determined
Cause 2		 Other
Action Unomedical Urgent Medical Device Correction letters were sent to distributors on January 22, 2010 by certified mail. Letters state that the only way to determine if the incorrect product is contained in the carton is to open the box. Distributors are asked to inspect all Diathermy Cables in their possession with order code 3508M or 3405M to ensure that the correct cable is inside. The number of mislabeled product is to be recorded on the Questionnaire for Distributors, and then mislabeled product is to be destroyed by cutting the product in half. The questionnaires include an area for names of customers stating that the distributor will contact them, or requesting that Unomedical contact them directly. Copies of the correction notice and questionnaire for end users are to be forwarded to all customers, asking them to complete the questionnaire and return it to the distributors. Once received by the distributors, end users can discard the cables by cutting them in half. All completed forms should be returned to Unomedical and local reps are to be contacted to arrange for replacement of mislabeled stock and/or credits.
Quantity in Commerce 5130 cables worldwide, 1270 in US.
Distribution Worldwide distribution.
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 = GEI and Original Applicant = NEW DEANTRONICS, LTD.
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