Z-2064-2018Class II

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

Name: Z-2064-2018 Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Creator: C.R. Bard, Inc.
Published: 2017-12-13
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-12-13 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522) on 2017-12-13. FDA classified it as Class II and gives the reason as "Foley Catheter with Incorrect Retainer Cap Print". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2064-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-13
Posted: 2018-06-06
Terminated: 2020-12-14
Recalling firm: C.R. Bard Inc
Product: Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Product code: EZC Catheter, Coude
Reason for recall: Foley Catheter with Incorrect Retainer Cap Print
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2064-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2064-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-06

Product code EZC

K910195Class IIBard Hydrogel-Coated Foley CathetersC.R. Bard, Inc. / cleared 1991-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)