FDA-Device2016-08-10Class III
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
C.R. Bard, Inc.
Hazard
Labeling problem
Sold states
Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
Affected count
530 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2333-2016Don't want to check this manually?
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