Recalls
FDA updates CareFusion ventilator recall
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.
FDA: H&H Medical recall is Class I
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.
Bard’s stent recall gets FDA highest-risk label
Another recall for HeartSine Technologies
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.
GE Healthcare warns on software issues in anesthesia systems
GE Healthcare (NYSE:GE) issued a field correction on certain of its Avance, Avance CS2 and Aisys anesthesia delivery systems, warning that they need a software update to avoid a potential safety issue.
Recall: Edwards Lifesciences pulls EMBOL-X devices over deformed tips
Medical device recalls for September 2013
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
CareFusion updates on Class I ventilator recall amid customer complaints
CareFusion (NYSE:CFN) issued an update on the recall of its AVEA ventilators after receiving 5 complaints from a clinical providing neonatal care. No injuries have yet been directly attributed to the issues with the ventilators, CareFusion noted.