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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