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Open, Classified

NavaClick Syringe and Needle, Model Number LIN02

FDA Recall Z-2535-2024 · Posted 2024-08-08

Recalling FirmLINEAGE BIOMEDICAL, INC
Recall StatusOpen, Classified
Product CodeFMF
Date Initiated2024-07-12
Product Quantity215 cartons (containing 50 pouches each)

Reason for Recall

Incorrect GTIN number on carton.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K231877NavaClick Injection SystemLineage Biomedical, Inc. · 2023-11-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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