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C.R. Bard, Inc. recalls Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for pati
Recalled August 17, 2016 · FDA recall Z-2345-2016 · C.R. Bard
Hazard
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected. · FDA Class III
Units
64
Sold at
US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
Description
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
Product
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Manufacturer(s)
C.R. Bard, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →