Device product
LUNA Chest, Model No. LU4006
Z-0469-2015
Product summary
- Event
- Event 69839
- Status
- Terminated
- Classification
- Class III
- Quantity
- 828 units
- Official record key
device-enforcement:Z-0469-2015
Official wording
Reason: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Code information: Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
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.
Derived failure modes
-
Labeling or packaging
mislabeled