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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

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

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

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

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

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.

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SGR cuts to take effect on June 1

Friday, May 28, 2010

With the Senate already adjourned for the Memorial Day recess, legislation to stave off Medicare payment cuts cannot be enacted, even if the House passes a bill today. As a result, a 21 percent Medicare payment cut will take effect for services provided on or after June 1.

It is expected that after the holiday, Congress will consider SGR provisions in some form.

CMS is instructing its contractors to hold claims containing services paid under the MPFS for the first 10 business days of June, while Congress continues its work on legislation. This hold will only affect MPFS claims with dates of service June 1, 2010, and later.

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