Lineage Biomedical, Inc. is recalling 215 cartons of NavaClick Syringe and Needle products (Model Number LIN02) because the Global Trade Item Number (GTIN) on the outer packaging is incorrect. Each affected carton contains 50 individually packaged pouches. This labeling error can lead to inventory management issues or potential confusion regarding the specific device version being used in clinical settings.
An incorrect GTIN on the packaging carton may lead to the selection or use of the wrong medical device, which could delay medical procedures or result in improper treatment if the user relies on automated scanning systems for device verification.
Manufacturer contact for clinical guidance.
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Sources: FDA iRES · Raw API Response
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