Showing posts with label decree. Show all posts
Showing posts with label decree. Show all posts

Wednesday, January 23, 2013

Invacare Gets Out Of The Medical Supplies Business

Invacare closes $150M unit sale as it reels from FDA fallout - FierceMedicalDevices:

"Invacare ($IVC) has wrapped up the $150.8 million sale of its medical supplies business to AssuraMed, planning to use the proceeds to pay down debt and get out from under an FDA consent decree."

'via Blog this'

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Monday, July 19, 2010

FDA Orders Baxter Colleague Pump Refunds and Replacements


The FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall - Company must provide transition guide for facilities using Colleague infusion pumps.
 
In brief, in a Colleague Pump - Consent Decree letter to two Baxter executives, the FDA orders Baxter to take the following actions:

  • Recall and destroy all Colleague infusion pumps covered by the Consent Decree that are manufactured, distributed, or sold by Baxter or that are under the custody and control of Baxter's agents, distributors, or customers from the US market..
  • Provide either a replacement infusion pump (other than the Colleague model) or refund to all owners, and a lease termination to all lessees, of Colleague infusion pumps no later than the date that is twenty four months after the date of this final order (“the transition period”).
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