Device product
Lugol s Iodine Solution 500ML, Part Number 624-71
Z-0408-2024
Product summary
- Event
- Event 93318
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0408-2024
Official wording
Reason: Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.
Code information: Lot Number 3124
Distribution pattern: US States: CA, NJ, WV
Derived failure modes
-
Labeling or packaging
incorrect packaging