Government of Canada recall portal · Canada · 2009-08-06
As described by Government of Canada recall portal: Archived – Medtronic Recalls Certain Lots of Paradigm Quick-Set Infusion Sets
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Archived by the issuing authority — kept for reference
Reported risk: Health Canada is advising Canadians that the company Medtronic has initiated a recall of its Quick-Set Paradigm infusion sets with lot numbers beginning with "8" (Lot 8). A small percentage of the affected infusion sets may work improperly and may deliver too much or too little insulin, which could cause serious health effects. Medtronic Paradigm Quick-Set infusion sets are used by patients with diabetes as part of intensive insulin therapy. An infusion set is a narrow-diameter tube that connects to an insulin pump to deliver insulin to the patient through a needle under the patient's skin. Patients using a Quick-Set Paradigm infusion set are advised to check the lot number of their product. (See the instructions provided below.) If the set is from Lot 8, Medtronic is advising patients to stop using it immediately. Infusion sets from any other lot can be used.
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