January 23, 2009
Company:Baxter Healthcare CorpDate of Enforcement Report 1/23/2009 Class:l PRODUCT Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps REASON The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, Illinois
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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