Recall Z-2535-2024 ยท FMF Syringe, Piston
LINEAGE BIOMEDICAL, INC
NavaClick Syringe and Needle, Model Number LIN02
| Date | Aug 8, 2024 (initiated Jul 12, 2024) |
| Status | Open, Classified |
| Reason | Incorrect GTIN number on carton. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 215 cartons (containing 50 pouches each) |
| Distribution | US Nationwide distribution in the states of Michigan and South Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231877 | NavaClick Injection System Lineage Biomedical, Inc., Nov 30, 2023 |