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Transonic Systems Inc recalls HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status
Recalled April 24, 2013 · FDA recall Z-1147-2013 · Transonic Systems
Hazard
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. · FDA Class II
Units
195 units total (140 units Domestic, 55 units Foreign)
Sold at
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.
Description
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Product
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.
Manufacturer(s)
Transonic Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →