FDA-Device2019-03-20Class I
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Cook Inc.
Hazard
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Sold states
US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.
Affected count
100
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2019Don't want to check this manually?
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