FDAFDA · Food and drugs·Recall number Z-2693-2020
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
Published July 29, 2020 · Recall initiated: June 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
- Lot
- Lot # BY19L009 BY20A012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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