Z-2535-2024 Class III Ongoing
FDA device recall Z-2535-2024 was initiated by LINEAGE BIOMEDICAL, INC on July 12, 2024 and is designated Class III. Reason for recall: Incorrect GTIN number on carton. The recall status is ongoing. Affected quantity: 215 cartons (containing 50 pouches each).
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- July 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215 cartons (containing 50 pouches each)
Product Description
NavaClick Syringe and Needle, Model Number LIN02
Reason for Recall
Incorrect GTIN number on carton.
Distribution Pattern
US Nationwide distribution in the states of Michigan and South Carolina.
Code Information
Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107