Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0825-2020 — TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

U.S. FDA — Device Enforcement · United States · 2019-03-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0825-2020
Date of alert
2019-03-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Acclarent, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10705031245884
Reported risk: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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