Recall Z-2535-2024
Lineage Biomedical, Inc · initiated July 12, 2024
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
NavaClick Syringe and Needle, Model Number LIN02
Codes / lots: Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107
Reason for recall
Incorrect GTIN number on carton.
FDA-determined cause: Error in labeling
Action taken
Lineage Biomedical notified consignees via UPS letter on 07/12/2024. The letter instructed consignees to relabel the product with the updated UDI barcode or return inventory on hand for replacement. Additionally, consignees were asked to acknowledge receipt of the notification.
Details
- Recall number
- Z-2535-2024
- Initiated
- July 12, 2024
- Posted by FDA
- August 8, 2024
- Product code
- FMF – Syringe, Piston
- Quantity
- 215 cartons (containing 50 pouches each)
- Distribution
- US Nationwide distribution in the states of Michigan and South Carolina.
- Recalling firm
- Lineage Biomedical, Inc, Stuart, FL