Device product

NavaClick Syringe and Needle, Model Number LIN02

Z-2535-2024

July 12, 2024

Class III

Product summary

Firm: LINEAGE BIOMEDICAL, INC
Event: Event 94963
Status: Ongoing
Classification: Class III
Quantity: 215 cartons (containing 50 pouches each)
Official record key: device-enforcement:Z-2535-2024

Official wording

Reason: Incorrect GTIN number on carton.

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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incorrect GTIN number on carton.