Z-0667-2022Class II

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

Name: Z-0667-2022 BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Creator: C.R. Bard Inc
Published: 2022-01-27
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2022-01-27 / Terminated

FDA source

C.R. Bard Inc began a recall of BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C on 2022-01-27. FDA classified it as Class II and gives the reason as "There is a potential to leak from the catheter where it connects to the drain bag". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0667-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-27
Posted: 2022-02-24
Terminated: 2026-07-10
Recalling firm: C.R. Bard Inc
Product: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Product code: KOD Catheter, Urological
Reason for recall: There is a potential to leak from the catheter where it connects to the drain bag
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.
Quantity in commerce: 1620 units
Distribution: US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
Product codes and lots: Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0667-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0666-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0667-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24

Product code KOD

K000723Class IIHydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)Rochester Medical Corp. / cleared 2000-05-19

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)