Z-0408-2024 Class II Ongoing
FDA device recall Z-0408-2024 was initiated by EMD Millipore Corporation on October 17, 2023 and is designated Class II. Reason for recall: 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 c… The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Lugol s Iodine Solution 500ML, Part Number 624-71
Reason for Recall
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.
Distribution Pattern
US States: CA, NJ, WV
Code Information
Lot Number 3124