Z-2154-2024Class II

Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care...

Name: Z-2154-2024 Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care...
Creator: C.R. Bard Inc
Published: 2024-05-09
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2024-05-09 / Open, Classified / root cause: design

FDA source

C.R. Bard Inc began a recall of Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley... on 2024-05-09. FDA classified it as Class II and gives the reason as "Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices". 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-2154-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-09
Posted: 2024-06-18
Recalling firm: C.R. Bard Inc
Product: Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. 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 of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Root cause tag: design
FDA root cause: Component design/selection
Action: The recalling firm issued letters on and dated 5/9/2024 via FedEx and email. The letter to medical facilities explained the issue, contained a copy of the label for each product and showed where to find the catalog number and lot number, provided the clinical impact, and advised clinical users to review and follow instructions provided in the field action communication to avoid potential health consequences in the future. The letter also said that if the device is currently in use and functioning appropriately, the device does not need to be replaced. Actions to be taken by the medical facilities were: (1) Immediately discontinue use of unused inventory; (2) Check all inventory locations for the affected products and immediately quarantine; (3) Record the inventory totals on the attached Customer Response Form then discard all affected product within the facility's control per the facility's procedures; (4) Share the notice with any users of the product within the facility or with any interfacility users where product was transferred to ensure they are also aware of the recall; (5) Complete and return the attached Customer Response Form to the BD contact noted on the form to confirm acknowledgment of the correction whether or not the consignee has any affected product. The letter to the distributors was similar to the medical facility letter except they were instructed to identify all customers within their distribution network who purchased the affected product and provide a copy of the attached customer letter to all customers to advise them of the field action notification. A Distributor Response Form was also attached to acknowledge receipt of the recall notification, indicate the quantity of product identified at the distributor, and confirm the inventory was destroyed.
Quantity in commerce: 6,420 devices
Distribution: Distribution was nationwide. There was no government/military/foreign distribution.
Product codes and lots: SureStep Foley Tray System - Lot #NGHZ1757, exp. 31Jan2026, UDI-DI 00801741073861 (eaches); 10801741073868 (case). Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray, Lot #NGHX2932, exp. 31May2025, UDI-DI 00801741024450 (each); 10801741024457 (case).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2154-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2154-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18

Product code MJC

K040658Class IIBardex I.c. Latex Foley CatheterC.R. Bard, Inc. / cleared 2004-09-29

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)