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07-13-2013, 10:15 AM #1
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Canadian Recall: Various Lots of Medtronic MiniMed Insulin Reservoirs
Recall of Various Lots of Medtronic MiniMed Insulin Reservoirs
Report a Concern
July 12, 2013
July 12, 2013
Type of communication:
Subcategory: Medical Device
Source of recall: Health Canada
Issue: Product Safety
Audience: General Public
Identification number: RA-34599
Medtronic of Canada Ltd., in consultation with Health Canada, is recalling select lots (see list below) of Paradigm Medtronic MiniMed Insulin Reservoirs, model # MMT-326A and MMT-332A, manufactured by Medtronic MiniMed. These insulin reservoirs are used with Paradigm insulin infusion pumps.
Medtronic is recalling these lots due to the potential risk of a leak in the reservoir that may result in under-delivery of insulin. As well, if there is an obstruction in the infusion set, the pump alarm may not be triggered. The under-delivery of insulin may cause hyperglycemia (high blood sugar), and in extreme cases may cause loss of consciousness or death.
Medtronic of Canada Ltd is notifying all customers who have purchased products from them of this recall and advising them to check their supplies to see if they have received affected lots. The lot number can be found on the side panel of the reservoir box and on the packaging of each individual reservoir.
Patients who have devices from the affected lots or who are concerned about this device should contact Medtronic of Canada Ltd.’s Diabetes Consumer Care line immediately at 1-800-284-4416 or email firstname.lastname@example.org. Patients who have health concerns related to their use of this device should speak with their health care professional.
Affected products Model Volume Lot Numbers Affected
MMT-326A 1.8 ml H8500423
MMT-332A 3. 0 ml H8471745
Report health or safety concerns
Complaints involving 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