FDA-Device2024-06-26Class II
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.
C.R. Bard Inc
Hazard
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Sold states
Distribution was nationwide. There was no government/military/foreign distribution.
Affected count
6,420 devices
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2154-2024Don't want to check this manually?
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