FDA-Device2021-09-29Class II

Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, 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
11,780 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2021

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