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U.S. Department of Health and Human Services

Class 2 Device Recall Totalis

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 Class 2 Device Recall Totalissee related information
Date Initiated by FirmOctober 13, 2016
Create DateNovember 14, 2016
Recall Status1 Terminated 3 on February 10, 2022
Recall NumberZ-0406-2017
Recall Event ID 75492
510(K)NumberK043193 K983498 
Product Classification Stent, ureteral - Product Code FAD
ProductTotalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Code Information Product Codes: REK32N and FEK32HW.
Recalling Firm/
Manufacturer
C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactMichael Wolfe
770-784-6220
Manufacturer Reason
for Recall
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
FDA Determined
Cause 2
Labeling Change Control
ActionBard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use. If you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This notification should be carried out to the user level. This product notification is being made with the knowledge of the Food and Drug administration. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. For further questions, please call (770) 784-6220.
Quantity in Commerce75,089 units
DistributionU.S. Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FAD
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