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 Hydroge

Hazard

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

Details from the source

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: Distribution was nationwide. There was no government/military/foreign distribution. Quantity: 6,420 devices Lot/code info: 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).

UPC codes

00801741073861, 10801741073868, 00801741024450, 10801741024457

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.