FDA-Device2021-09-29Class II
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
C.R. Bard Inc
Hazard
There is potential for packaging defects that may impact the sterile barrier.
Sold states
US Nationwide distribution.
Affected count
5950 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2527-2021Don't want to check this manually?
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