Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
By Chris Walker
Stryker (NYSE:SYK) said yesterday that the cost of the recalls of its Rejuvenate and ABG II hip implants could top $1 billion, nearly double its prior estimate.
The Kalamazoo, Mich.-based orthopedic medical device company said in a regulatory filing that it now expects the recalls to cost between $700 million and $1.13 billion.
The FDA updated the Class I recall of CareFusion‘s (NYSE:CFN) AVEA ventilators, to include those used on infants under 5.5 pounds at altitudes above 5000 feet.
The FDA classified H&H Medical Corp.’s recall of its emergency cricothyrotomy kit as Class I.
The recall was issued because the kit’s endotracheal tube cuff balloon may not inflate properly.
HeartSine Technologies issued a voluntary recall of some defibrillators models because of a defect that could lead to death.
The Belfast, U.K.-based medical device company said some of its older PDU 400 personal defibrillators were pulled because of a self-test defect that allows them to appear to be ready for use, despite having insufficient battery power.