FDA-Device2017-12-27Class II
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿
C.R. Bard, Inc.
Hazard
Hydrogel peeling from the pads.
Sold states
US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY
Affected count
24
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2018Don't want to check this manually?
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