Health Canada — Marketed Health Products · Canada · 2003-11-06
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Reported risk: Physician/Healthcare Provider - Urgent Product Recall on Dahedi Insulin Pumps Following an inspection of our infusion pump manufacturing facility, the U.S. Food and Drug Administration (FDA) determined that our manufacturing processes are not in substantial compliance with the regulations. In the absence of compliance with these regulations, the reliability of devices cannot be assured, which could potentially result in problems with the product leading to under and/or over infusion of insulin. Health Canada has asked that we inform you of this issue.
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