January 12, 2012
Summary:
FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.
January 12, 2012
Summary:
Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.
January 09, 2012
Summary:
FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.