News Column

Recall of Various Lots of Medtronic MiniMed Insulin Reservoirs

Jul 12 2013 12:00AM

Marketwire

LogoTracker

OTTAWA, ONTARIO -- (Marketwired) -- 07/12/13 -- Medtronic 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 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 Canada Ltd.'s 24-hour product support line at 1-800-646-4633. Patients who have health concerns related to their use of this device should speak with their health care professional.

------------------------------------------------------------------------Model Volume Lot Numbers Affected------------------------------------------------------------------------MMT-326A 1.8 ml H8500423 H8500472 H8503728 H8539013 H8510440 H862775------------------------------------------------------------------------MMT-332A 3.0ml H8471745 H8469703 H8473106 H8473271 H8476270 H8492449 H8492449 H8496561 H8517079------------------------------------------------------------------------



How to report side effects to health products:

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 InspectorateHealth CanadaAddress Locator: 2003DOttawa, Ontario K1A 0K9



Egalement disponible en francais



Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709





Source: Marketwire


Story Tools