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MesireTM Illuminus - Sinus Light Wire

MERIL LIFE SCIENCES PRIVATE LIMITED · Model MSI083 · UDI-DI 18904224901541

LRC Prescription
1
510(k) clearances
557
Adverse events (13 deaths)
5
Recalls
219
Facilities

Description

MesireTM Illuminus -Sinus Light Wire, 0.83 mm

Recalls

DateFirmReason
2024-12-19Karl Storz EndoscopyDue to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
2024-02-27Karl Storz EndoscopyInadequate reprocessing validation evidence
2023-10-24Karl Storz EndoscopyThe efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa
2013-05-24Gyrus Acmi, Incorporatedlack of sterility assurance
2006-01-20Acclarent IncDevice sterility may be compromised as evidenced by a loss of package integrity.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.