C.R. Bard product recalled over fire hazard

Recall date

October 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

C.R. Bard, Inc. recalls Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set…

Recall number

Z-0271-2018

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY

Why it was recalled

Hydrogel peeling from the pads.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.¿