C.R. Bard, Inc. recalls Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patien…
- Recall date
- June 30, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2345-2016
- FDA classification
- Class III
- Brand / firm
- C.R. Bard, Inc.
- Sold / distributed
- 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
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
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