NavaClick Syringe and Needle, Model Number LIN02

FDA Recall #Z-2535-2024 — Class III — July 12, 2024

Recall #Z-2535-2024 Date: July 12, 2024 Classification: Class III Status: Ongoing

Product Description

NavaClick Syringe and Needle, Model Number LIN02

Reason for Recall

Incorrect GTIN number on carton.

Recalling Firm

LINEAGE BIOMEDICAL, INC — Stuart, FL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

215 cartons (containing 50 pouches each)

Distribution

US Nationwide distribution in the states of Michigan and South Carolina.

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated