FDA-Device2014-12-03Class III
LUNA Chest, Model No. LU4006
Novadaq Technologies, Inc.
Hazard
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Sold states
Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
Affected count
828 units
Manufactured in
13155 Delf Place, N/A, Richmond, British Columbia, Canada
Products
LUNA Chest, Model No. LU4006
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0469-2015Don't want to check this manually?
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