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U.S. Department of Health and Human Services

Class 2 Device Recall DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560

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  Class 2 Device Recall DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 see related information
Date Initiated by Firm March 11, 2010
Date Posted April 22, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-1431-2010
Recall Event ID 54975
510(K)Number K990113  
Product Classification electrode, electrocardiograph - Product Code DRX
Product Unilect ECG Electrodes
Unomedical, McAllen Texas.

Intended use:Cardiac monitoring
Code Information Model Number 4560M; Lots: 706268, 708152, 709705, 711967, 713648, 713977, 714391, 714392, 714685, 714687.
Recalling Firm/
Manufacturer		 ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558
For Additional Information Contact John Holburt
908-904-2675
Manufacturer Reason
for Recall		 In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.
FDA Determined
Cause 2		 Process design
Action The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a "URGENT : MEDICAL DEVICE RECALL" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product. If you have any questions, please contact Convatec at 908-904-2425.
Quantity in Commerce 567,000 units
Distribution Nationwide distribution: CA
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 = DRX and Original Applicant = MAERSK MEDICAL A/S
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