NavaClick Syringe and Needle, Model Number LIN02
FDA device recall Z-2535-2024 · posted 2024-08-08 · Open, Classified
Recall details
- Recalling firm
- LINEAGE BIOMEDICAL, INC
- Reason for recall
- Incorrect GTIN number on carton.
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- FMF
- Quantity affected
- 215 cartons (containing 50 pouches each)
- Distribution
- US Nationwide distribution in the states of Michigan and South Carolina.
- Date initiated
- 2024-07-12
- Date posted
- 2024-08-08
- Location
- Stuart, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NavaClick Injection System (K231877) | Lineage Biomedical, Inc. | 2023-11-30 |