FDA-Device2014-04-16Class II
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Smiths Medical ASD, Inc.
Hazard
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Sold states
Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
Affected count
870 units
Manufactured in
160 Weymouth St, N/A, Rockland, MA, United States
Products
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2014Don't want to check this manually?
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