Baxter Colleague FDA Ordering Recall

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百特的 Colleague 有問題，被全面回收

Baxter Colleague Infusion Pumps: FDA Ordering RecallAudience: Hospital Risk Managers

[Posted 05/04/2010]
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use.

FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

[05/03/2010 - [url=/NewsEvents/Newsroom/PressAnnouncements/ucm210664.htm]News Release[/url]1 - FDA]Previous MedWatch Alert:[[url=/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127777.htm]03/12/2009[/url]2]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm