Z-2154-2024 Class II Ongoing
FDA device recall Z-2154-2024 was initiated by C.R. Bard Inc on May 9, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6,420 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 26, 2024
- Initiation Date
- May 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,420 devices
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.
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.
Distribution Pattern
Distribution was nationwide. There was no government/military/foreign distribution.
Code Information
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).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2154-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026