FDA-Device2021-09-29Class II
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, 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
11,600 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2021Don't want to check this manually?
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