FDA Enforcement
Class III
Ongoing
NavaClick Syringe and Needle, Model Number LIN02
Recall: Z-2535-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2535-2024
- Event ID
- 94963
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- LINEAGE BIOMEDICAL, INC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2024
- Initiation Date
- July 12, 2024
- Classification Date
- August 8, 2024
- Address
- 620 Nw Dixie Hwy, Stuart, FL, 34994-1165, United States
Description
NavaClick Syringe and Needle, Model Number LIN02
Reason
Incorrect GTIN number on carton.
Code Info
Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107
Distribution
US Nationwide distribution in the states of Michigan and South Carolina.
Quantity
215 cartons (containing 50 pouches each)