Summary
The FDA issued a Class III for NavaClick Syringe and Needle, Model Number LIN02 by LINEAGE BIOMEDICAL, INC. Reason: Incorrect GTIN number on carton..
Details
Source
Device Recall
External ID
Z-2535-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
NavaClick Syringe and Needle, Model Number LIN02
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
Quantity Affected: 215 cartons (containing 50 pouches each)
Reason for Recall
Incorrect GTIN number on carton.
Distribution
US Nationwide distribution in the states of Michigan and South Carolina.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-12
Company
Stuart, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LINEAGE BIOMEDICAL, INC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LINEAGE BIOMEDICAL, INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LINEAGE BIOMEDICAL, INC have FDA actions?
LINEAGE BIOMEDICAL, INC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2535-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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