Acclarent recalls TruDi NAV Suction instruments with calibration issues causing incorrect tip orientation display. Affected lots: 1901080, 1901177, 1901219. No immediate action needed but check for calibration issues.
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Acclarent is recalling TruDi NAV Suction instruments that may show incorrect tip orientation due to calibration issues. This could lead to improper use during medical procedures. The recall affects specific production lots.
The calibration issues cause the instruments to display incorrect tip orientation in the system. This could lead to improper placement during medical procedures if the tip is not aligned correctly. However, the risk is not immediate or life-threatening.
Medical professionals using the TruDi NAV Suction instruments for procedures are most at risk. Patients using these instruments during surgery may be affected if the tip orientation is incorrect.
Check for lot numbers 1901080, 1901177, or 1901219 on the TruDi NAV Suction instruments. The product is labeled as 'TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle'.
Verify the instrument's calibration status by checking the lot number on the product.
The instruments may display incorrect tip orientation due to calibration issues, which could lead to improper placement during medical procedures.
Lots 1901080, 1901177, and 1901219 are affected.
No immediate action is required, but you should check the calibration status if you have the affected lot numbers.
We’ve drafted a message you can send Acclarent to request your refund or repair — edit it as you like.
Subject: Recall Z-0826-2020 — Acclarent Acclarent Hello, I own a Acclarent that is covered by recall Z-0826-2020 from Acclarent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
