Product Wiki · Recalls · Government of Canada recall portal

Recall of Various Lots of Medtronic MiniMed Insulin Reservoirs — recall 50001

Government of Canada recall portal · Canada · 2013-07-12

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Agency
Government of Canada recall portal
Recall identifier
50001
Date of alert
2013-07-12
Country / jurisdiction
Canada
Risk type
recall
Product category
Medical devices
Product type
Communications and Public Affairs Branch
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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 [NJS_FILE:3dd32d88-8ed3-4649-9b5d-64e7ed5b1795:d3a91320-3e1b-43c5-9405-92e1afd6d065] 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 [email protected] . Patients who have health concerns related to their use of this device should speak with their health care professional.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/recall-various-lots-medtronic-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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