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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

C.R. Bard Inc: Foley Catheter Tray Systems Recalled for Incorrect Temperature Readings

Agency Publication Date: June 18, 2024
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Summary

C.R. Bard Inc. is recalling approximately 6,420 SureStep and Bardex IC Foley Tray Systems because the temperature-sensing devices may malfunction. This defect can lead to no temperature display or erratic, inaccurate temperature readings being shown on monitoring equipment. These trays are medical kits used for the drainage, collection, and measurement of urine in clinical settings. Consumers should contact their healthcare provider or the manufacturer regarding the affected devices.

Risk

Incorrect or missing temperature data can prevent medical staff from accurately monitoring a patient's core body temperature. This failure may lead to a delay in recognizing fever or other critical changes in a patient's medical condition.

What You Should Do

  1. Check your medical supplies for the Bard Medical SureStep Foley Tray System (16 Fr.) with Catalog #A319416AM and Lot #NGHZ1757 (Exp. 31Jan2026).
  2. Check your medical supplies for the Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray (16 Fr.) with Catalog #319416AM and Lot #NGHX2932 (Exp. 31May2025).
  3. Verify the Unique Device Identifier (UDI) on the packaging: 00801741073861 (Each) or 10801741073868 (Case) for SureStep; 00801741024450 (Each) or 10801741024457 (Case) for Bardex IC.
  4. If you identify an affected product, contact your healthcare provider or C.R. Bard Inc. immediately for further instructions and potential refund options.
  5. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Bard Medical SureStep Foley Tray System (16 Fr.)
Model / REF:
A319416AM
UPC Codes:
00801741073861
10801741073868
Lot Numbers:
NGHZ1757 (Exp. 31Jan2026)
Date Ranges: Exp. 31Jan2026
Product: Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray (16 Fr.)
Model / REF:
319416AM
UPC Codes:
00801741024450
10801741024457
Lot Numbers:
NGHX2932 (Exp. 31May2025)
Date Ranges: Exp. 31May2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94722
Status: Active
Manufacturer: C.R. Bard Inc
Sold By: medical distributors; healthcare facilities
Manufactured In: United States
Units Affected: 6,420 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.