Z-2692-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 8, 2020
- Termination Date
- May 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2415 pk
Product Description
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - 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.
Reason for Recall
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Code Information
Lot # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009