FDAClass IIJanuary 29, 2020

TruDi NAV Suction recall

TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

Why was TruDi NAV Suction recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Recalling firm
Acclarent, Inc.
Distribution
US: WI, IL, NE, CA, OH, NY OUS: None
Recall date
January 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls