Z-1358-2016Class II

BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients...

Name: Z-1358-2016 BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients...
Creator: C.R. Bard, Inc.
Published: 2015-12-18
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-12-18 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of... on 2015-12-18. FDA classified it as Class II and gives the reason as "Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume". 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-1358-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-04-08
Terminated: 2016-06-29
Recalling firm: C.R. Bard Inc
Product: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.
Quantity in commerce: 1,428,000 units (total)
Distribution: Distributed US (nationwide) and the countries of Canada and Australia.
Product codes and lots: Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1358-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1357-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1358-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1359-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08

Product code MJC

K910318Class IIBard(r) Hydrogel/silver-Coated Foley CatheterC.R. Bard, Inc. / cleared 1994-08-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)