C.R. Bard Inc: 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.

Recall number

Z-2154-2024

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.

Status

Open, Classified

Initiated

2024-05-09

Posted

2024-06-18

Terminated

not on file

Reason

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

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

6,420 devices

Distribution

Distribution was nationwide. There was no government/military/foreign distribution.

Lot, serial or model codes

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).

510(k) numbers

["K040658"]

PMA numbers

not on file

Product code

MJC

Firm FEI

1018233

Firm city

Covington

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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