Health Canada — Marketed Health Products · Canada · 2003-11-06
As described by Health Canada — Marketed Health Products: Archived – Important Medical Devices Safety Information – Safety Alert on Your Panomat Infusion Pump
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Archived by the issuing authority — kept for reference
Reported risk: 03-161 August 25, 2003 Canada Physician/Healthcare Provider - Urgent Safety Alert On Your Panomat Infusion Pump 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 medication. Health Canada has asked that we inform you of this issue.
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