Reported Jan 29, 2020 · Terminated
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Acclarent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acclarent, Inc. · 33 Technology Dr · Irvine, CA · 92618-2346
Is this the product you have?
TruDi NAV SuctionTDNS000Z0 Degree Tip Angle(01)10705031245877
- Lot codes and dates
- Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
- Amount recalled
- 14 Suction Insstruments
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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