OTTAWA, March 8, 2013 /CNW/ - Health Canada is informing Canadians and Canadian health care practitioners that Hospira Inc., a drug and medical device manufacturer, is voluntarily stopping all new sales of its intravenous infusion pumps while it addresses issues in its quality management system.
Health Canada is monitoring Hospira's actions to resolve any quality, safety and effectiveness issues related to its infusion pumps sold in Canada and will take corrective action necessary to protect the health and safety of Canadians.
Intravenous infusion pumps are used extensively in hospitals, clinics and sometimes in home care or hospice settings to deliver intravenous fluids, medication, nutrition or blood to patients. Hospira has several brands of infusion pumps: Plum Infusion System, Symbiq Infusion System, LifeCare PCA Infusion System and GemStar Infusion System.
Hospira is continuing to communicate with hospitals and purchasers for clinic and home care use of these devices. At this time, Health Canada is not advising hospitals to stop using the Hospira infusion pumps in their facilities. Patients receiving therapies delivered by a Hospira infusion pump in a home setting should not stop using these devices unless they are advised to do so by their health care provider.
Patients currently using any Hospira infusion pumps in home settings are also encouraged to contact their health care provider to determine if their pumps are still suitable for their treatment. Patients may also wish to contact their infusion pump provider regarding correction instructions for their particular infusion pump.
Hospira has issued notices and correction instructions to those who have already purchased about existing infusion pump products. Canadians can contact Hospira for future updates regarding its various infusion pumps and pumps accessories. For more information, please contact 1-866-488-6088 or via email: [email protected].
Complaints about medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
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SOURCE: Health Canada
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