Z-0010-2013Class II

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually...

Name: Z-0010-2013 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually...
Creator: C.R. Bard, Inc., Urological Division
Published: 2012-09-07
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2012-09-07 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc., Urological Division began a recall of 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is... on 2012-09-07. FDA classified it as Class II and gives the reason as "The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap". 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-0010-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Posted: 2012-10-04
Terminated: 2013-03-21
Recalling firm: C.R. Bard Inc
Product: 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Product code: KOD Catheter, Urological
Reason for recall: The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.
Quantity in commerce: 4,032 units
Distribution: Nationwide distribution: USA and Puerto Rico
Product codes and lots: Catalog # 165808, Lot # NGWA1111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0010-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0010-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-04

Product code KOD

K821745Class IIBardex All Silicone Pediatric CatheterC.R. Bard, Inc. / cleared 1982-06-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)