FDA-Device2019-02-13Class II
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Bard Medical Division
Hazard
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Sold states
US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
Affected count
450 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. 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-0800-2019Don't want to check this manually?
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