Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Enforcement
- Recall Number
- Z-0223-2022
- Event ID
- 88808
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cook Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 24, 2021
- Initiation Date
- October 8, 2021
- Classification Date
- November 12, 2021
- Termination Date
- February 14, 2024
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
Description
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
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Domestic distribution nationwide. Foreign distribution worldwide.
4789 (OUS only)