FDA-Device2014-08-13Class II
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
ICU Medical, Inc.
Hazard
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Sold states
Worldwide Distribution - USA including Oregon and Internationally to Australia.
Affected count
60 units
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2014Don't want to check this manually?
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