NavaClick Syringe and Needle, Model Number LIN02
This recall is currently active, issued August 8, 2024. It was issued by Lineage Biomedical, Inc.
- Company
- Lineage Biomedical, Inc
- Recall Initiated
- July 12, 2024
- Posted
- August 8, 2024
- Recall Number
- Z-2535-2024
- Quantity
- 215 cartons (containing 50 pouches each)
- Firm Location
- Stuart, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect GTIN number on carton.
Distribution
US Nationwide distribution in the states of Michigan and South Carolina.
Lot / 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
Root 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.