FDA recall Z-0271-2018

Product

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.¿

Reason for recall

Hydrogel peeling from the pads.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-10-16

Report date

2017-12-27

Termination date

2020-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2018