C.R. Bard, Inc. recalls BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controll…
- Recall date
- March 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1395-2016
- FDA classification
- Class II
- Brand / firm
- C.R. Bard, Inc.
- Sold / distributed
- Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan,…
Why it was recalled
Complaints were received of restricted/inaccurate flow rate.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
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