FDA-Device2021-11-24Class II
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
Cook Inc.
Hazard
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.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
4789 (OUS only)
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2022Don't want to check this manually?
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