Z-1431-2021Class II

Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) -

Name: Z-1431-2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) -
Creator: C.R. Bard, Inc.
Published: 2021-01-11
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2021-01-11 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc. began a recall of Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only on 2021-01-11. FDA classified it as Class II and gives the reason as "The device catheter tip was cut off (no tip) and the product packaging was not fully sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1431-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-11
Posted: 2021-04-16
Terminated: 2023-02-02
Recalling firm: C.R. Bard Inc
Product: Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Product code: KOD Catheter, Urological
Reason for recall: The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: All customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components.
Quantity in commerce: 9,800 Units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
Product codes and lots: Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1431-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-16

Product code KOD

K802665Class IITouchless Clean-CathDiamed Division Ill. Tool Works, Inc. / cleared 1980-11-12

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)