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U.S. Department of Health and Human Services

Class 3 Device Recall Bardex Lubricath

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  Class 3 Device Recall Bardex Lubricath see related information
Date Initiated by Firm August 29, 2002
Date Posted August 21, 2003
Recall Status1 Terminated 3 on September 19, 2003
Recall Number Z-1144-03
Recall Event ID 26828
510(K)Number K984136  
Product Classification Catheter, Urological (Antimicrobial) And Accessories - Product Code MJC
Product Bardex¿ Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.
Code Information Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd NE
Covington GA 30014
For Additional Information Contact Wayne Williamson
770-784-6925
Manufacturer Reason
for Recall		 On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 8/29/2002. They were advised to pretest the catheter prior to inserting the catheter into the urethra.If the pretest indicates that the catheter balloons do not inflate as labeled, they were advised not to use the product and to contact Bard Medical Division Field Assurance Manager to have the product returned and credited.
Quantity in Commerce 1461 units
Distribution The product was distributed nationwide, Canada, Belgium and Germany.
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 = BARD MEDICAL DIV.
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