Z-0800-2019Class II

BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley...

Name: Z-0800-2019 BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley...
Creator: Bard Medical Division
Published: 2018-12-06
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2018-12-06 / Open, Classified / root cause: design

FDA source

Bard Medical Division began a recall of BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver... on 2018-12-06. FDA classified it as Class II and gives the reason as "Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0800-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-12-06
Posted: 2019-02-05
Recalling firm: C.R. Bard Inc
Product: BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Root cause tag: design
FDA root cause: Device Design
Action: Bard Medical Division notified customers on about 12/06/2018 via "MEDICAL DEVICE PRODUCT NOTIFICATION" letter. Customers were instructed to examine their inventory and identify any product subject to the recall, product return is not required, and if product was further distributed or transferred to notify those customers and include a copy of the medical device communication letter provided. Questions can be directed to Customer Service at 1-800-526-4455 or [email protected].
Quantity in commerce: 450 units
Distribution: US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
Product codes and lots: Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0800-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-13	2019-02-05

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