FDA (Devices) recall action 84398
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.