Class 3 Device Recall NavaClick Syringe and Needle

• Date Initiated by Firm: July 12, 2024
• Date Posted: August 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2535-2024
• Recall Event ID: 94963
• 510(K)Number: K231877
• Product Classification: Syringe, piston - Product Code FMF
• Product: NavaClick Syringe and Needle, Model Number LIN02
• Code Information: Product Level Labeling Full UDI: (01)00860009080522(17)250416(10)24107. Packaging Carton Level Labeling Full UDI: (01)208600090805(17)250416(10)24107
• Recalling Firm/ Manufacturer: LINEAGE BIOMEDICAL, INC; 620 Nw Dixie Hwy; Stuart FL 34994-1165
• For Additional Information Contact: Karen Mcmillen; 772-539-9749
• Manufacturer Reason for Recall: Incorrect GTIN number on carton.
• FDA Determined 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 in Commerce: 215 cartons (containing 50 pouches each)
• Distribution: US Nationwide distribution in the states of Michigan and South Carolina.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMF