FDA-Device2014-12-03Class III

Non-sterile drape

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
324 units
Manufactured in
13155 Delf Place, N/A, Richmond, British Columbia, Canada
Products
Non-sterile drape

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2015

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