FDA-Device2021-09-29Class II

Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, 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
10,150 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2021

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