Retiro De Equipo (Recall) de Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter

Recall

80150

Class 2

Z-2064-2018

2017-12-13

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164685

Foley catheter with incorrect retainer cap print.

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.