FDA-Device2021-11-24Class II
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
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
31,502 US (30,166 OUS)
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief