TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Reported: January 29, 2020 Initiated: March 6, 2019 #Z-0826-2020
Product Description
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Reason for Recall
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Details
- Recalling Firm
- Acclarent, Inc.
- Distribution
- US: WI, IL, NE, CA, OH, NY OUS: None
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891. Recalled by Acclarent, Inc..
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0826-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11