Z-0469-2015 Class III Terminated
FDA device recall Z-0469-2015 was initiated by Novadaq Technologies, Inc. on November 4, 2014 and is designated Class III. Reason for recall: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. The recall status is terminated (terminated November 6, 2015). Affected quantity: 828 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- November 4, 2014
- Termination Date
- November 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 828 units
Product Description
LUNA Chest, Model No. LU4006
Reason for Recall
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Distribution Pattern
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.
Code Information
Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282