Health Canada — Medical Devices · Canada · 2013-10-28 · Type II
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Reported risk: Baxter will commence a remediation strategy whereby all current Colleague pump customers will be provided with a newly manufactured Colleague P1.7A pump, software version 8.01.90 (EN) or 8.11.90 (FR) in exchange for each existing pump with an earlier software version. This remediation is being conducted to correct pump issues previously communicated on January 29, 2009 (Recall number 45280, Baxter reference 2008FCA18) and to provide other software and mechanical upgrades.
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