C.R. Bard Inc recalls Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection

Recalled June 26, 2024 · FDA recall Z-2154-2024 · C.R. Bard

Hazard

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

Units

6,420 devices

Sold at

Distribution was nationwide. There was no government/military/foreign distribution.

Description

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

Product

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.

Manufacturer(s)

C.R. Bard Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →