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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- C.R. Bard Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot 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).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2154-2024
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