Existing Baxter Notices
You may obtain paper copies of the notices that Baxter has issued for the COLLEAGUE pump by contacting Baxter at 1-800-843-7867. For your convenience, we have listed these notices below. You may access a notice by clicking on it . Please note that we cannot assure that the recommendations in these notices will fully address problems with the COLLEAGUE pump.
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December 13, 2005 Urgent Device Correction
July 20, 2005 Urgent Product Recall
March 15, 2005 Urgent Device Correction
February 25, 2005 Important Product Information
FDA Contact
Office of Surveillance and Biometrics (HFZ-510)
1350 Piccard Drive, Rockville, Maryland 20850
Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov
Additionally, a voice mail message may be left at 301-594-0650 and your call will be returned as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.
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Sincerely yours,
Daniel Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration
*CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.
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