FDA-Device2013-04-24Class II
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Transonic Systems Inc
Hazard
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Sold states
Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.
Affected count
195 units total (140 units Domestic, 55 units Foreign)
Manufactured in
34 Dutch Mill Rd, Warren Road Business Park, Ithaca, NY, United States
Products
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2013Don't want to check this manually?
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