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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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