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