Device product
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Z-2148-2016
Product summary
- Event
- Event 74030
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,440 cases ( 34, 560 retail - units )
- Official record key
device-enforcement:Z-2148-2016
Official wording
Reason: Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
Code information: Shipper case lot #8008580, Retal Carton Lot #4543U8008580
Distribution pattern: US Nationwide
Derived failure modes
-
Labeling or packaging
incorrectly labeled