The FDA reclaims a Johnson & Johnson heart device, claiming a faulty valve, in a Class I recall.
According to CNBC, recent article – The U.S. Food and Drug Administration issued a recall on Tuesday regarding a heart device made by Johnson & Johnson, claiming a faulty valve:
About 110 heart devices made and distributed by a unit of Johnson & Johnson between Jan. 1 and May 5 are a part of the Class I recall, according to the FDA.
A Class I recall is the strictest form of recall issued by the health regulator, in situations where the use of faulty devices may cause serious injury or death.
More details click: https://www.cnbc.com/2018/01/02/fda-issues-recall-on-johnson-johnson-heart-device.htm
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