Z-1144-03

Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath...

Name: Z-1144-03 Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath...
Creator: C.R. Bard, Inc., Urological Division
Published: 2002-08-29
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2002-08-29 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc., Urological Division began a recall of 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... on 2002-08-29. The reason FDA records is "On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1144-03
Status: Terminated
Initiated: 2002-08-29
Posted: 2003-08-21
Terminated: 2003-09-19
Recalling firm: C.R. Bard Inc
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.
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).

Product code MJC

K984136Class IIBardex Lubri-Sil I.c. Foley CatheterBard Medical Div. / cleared 1999-02-16

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)