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U.S. Department of Health and Human Services

Class 2 Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter

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  Class 2 Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter see related information
Date Initiated by Firm December 13, 2017
Create Date June 06, 2018
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-2064-2018
Recall Event ID 80150
510(K)Number K910195  
Product Classification Catheter, coude - Product Code EZC
Product Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Code Information Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Customer Service
800-526-4455
Manufacturer Reason
for Recall		 Foley Catheter with Incorrect Retainer Cap Print
FDA Determined
Cause 2		 Process control
Action On December 13, 2017 a letter was sent to all their customers informing them of the following: Bard Medical Division (BMD), C.R Bard, Inc., would like to inform you of a potential labeling issue involving the BARD product code and lot numbers listed below. Manufacturing of these affected products began May 2017.Due to a manufacturing issue, there is a potential for catheters with the two lot numbers listed above to have the incorrect information printed on the purple retainer cap. The incorrect print specifies that the balloon should be inflated with 10mL of water. However, the correct volume to use to inflate the catheter balloon is 75cc . If the user underinflates the balloon with only 10mL of water, the expected effect of helping stop the bleeding as an adjunct to conventional hemostasis post-TURP may not happen as quickly as desired, likely leading to a marginal severity of harm. Additionally, the catheter may become dislodged from the patient. Instructions to Customer: "Examine your inventory and identify any product subject to this communication. During use, adhereto the correct inflation volume as stated in the packaging. "Product return is not required. If a unit does not meet your needs or you have any questions,please contact our customer service at 1-800-526-4455. "If you have further distributed or transferred this product, please identify the respective organizationsand notify them at once of this product communication. Your notification to these organizations maybe enhanced by including a copy of this medical device communication letter. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. If you have any questions please do not hesitate to contact your Bard representative.
Distribution FL, NY, MN and TX Canada, Japan and Taiwan
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 = EZC and Original Applicant = C.R. BARD, INC.
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