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U.S. Department of Health and Human Services

Class 3 Device Recall Antibacterial Hydro Personal Catheter

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  Class 3 Device Recall Antibacterial Hydro Personal Catheter see related information
Date Initiated by Firm October 02, 2015
Date Posted November 02, 2015
Recall Status1 Terminated 3 on August 01, 2016
Recall Number Z-0198-2016
Recall Event ID 72398
510(K)Number K033477  
Product Classification Catheter, urological (antimicrobial) and accessories - Product Code MJC
Product Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Code Information Lot 53620131
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Sherry Saurini
770-784-6119
Manufacturer Reason
for Recall		 Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
FDA Determined
Cause 2		 Error in labeling
Action Bard sent a Customer Notification Letter dated September 29 to customers via FedEx with proof of delivery notice. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to carry out the notification to the user level. Customers with questions were instructed to contact BMD at 1-770-784-6471.
Quantity in Commerce 4,170 each
Distribution Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
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 = MJC and Original Applicant = ROCHESTER MEDICAL CORP.
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