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Recall Observatory FDA recall evidence

Device product

TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891

Z-0826-2020

March 06, 2019

Class II

Product summary

Firm
Acclarent, Inc.
Event
Event 84398
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0826-2020

Official wording

Reason: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

Code information: Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

Distribution pattern: US: WI, IL, NE, CA, OH, NY OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.