FDA (Devices) recall action 69839
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Novadaq Technologies is recalling 828 LUNA Chest units because non-sterile drapes were inadvertently mislabeled as sterile.
Novadaq Technologies is recalling 324 non-sterile LUNA drapes that were inadvertently mislabeled with an additional contents sterile label.