Archived – Medtronic Recalls Certain Lots of Paradigm Quick-Set Infusion Sets

Starting date:

August 6, 2009

Posting date:

August 6, 2009

Type of communication:

Advisory

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Medical Devices, Product Safety

Audience:

General Public

Identification number:

RA-110002947

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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.

Patients can contact Medtronic of Canada directly to arrange the return of any Lot 8 infusion sets and receive a replacement product. Information about the recall is available on the Medtronic website, or by telephone between 8:30 a.m. and 7:00 p.m. (Eastern time) at

1-800-284-4416. Patients with any questions or concerns regarding a medical device they are using should contact their pharmacist or health care professional.

An insulin under-dose could result in high blood sugar (hyperglycemia), while an insulin overdose could lead to low blood sugar (hypoglycemia). Both high and low blood sugar should be recognized and treated promptly to avoid serious complications.

The recalled Lot 8 Quick-Set Paradigm infusion sets were manufactured by Medtronic primarily for distribution in the United States. Limited quantities of these sets were also distributed in Canada by various distributors. Health Canada is monitoring the recall and has also issued a Notice to Hospitals informing health care professionals of the recall.

How to locate the lot number on the infusion set packaging

The lot number is clearly marked on both the box label and on each individual infusion set package (see below). This product recall affects only Lot 8 Quick-Set Paradigm infusion sets with the following reference numbers: MMT-396, MMT-397, MMT-398 and MMT-399.

Box Label

Individual Package Label

Problems involving Medtronic Quick-Set Paradigm infusion sets or any other medical device 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

Health Canada

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709

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