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Bard Medical SureStep Foley Tray System, 16 Fr., Catalog… recallZ-2154-2024 · C.R. Bard Inc · initiated May 9, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from C.R. Bard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2154-2024
Status
Open, Classified
Initiated by the company
May 9, 2024
Posted by the FDA
Jun 18, 2024
Recalling firm
C.R. Bard Inc
Quantity
6,420 devices
Product code
MJC
FDA submissions
K040658
Distribution
Distribution was nationwide. There was no government/military/foreign distribution.

Product description

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.

Code information (models, lots, serial numbers)

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).

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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