FDAFDA · Food and drugs·Recall number Z-0469-2015
LUNA Chest, Model No. LU4006
Published December 3, 2014 · Recall initiated: November 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Novadaq Technologies, Inc.
- Distributor
- 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.
- Lot
- Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Canada
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