Medtronic Recalls 60,000 Paradigm Quick-Set Infusion Sets

-US Recall News

07/14/2009 - Medtronic has issued a recall of specific lots of infusion sets that are for use with MiniMed Paradigm insulin pumps. These infusion sets may not work properly, resulting in a delivery of too little or too much insulin, which could result in injury or death.

The infusion set is the thin plastic tube that delivers insulin from the pump to the diabetes patient. They are typically replaced every three days by the patient. Four different styles of infusion sets are affected, with reference numbers MMT-396, -397, -398, and -399. All affected infusion kits (about 60,000) have lot numbers beginning with the number 8, and are referred to in the recall as “ Lot 8″ Quick-Set infusion sets.

To find out whether your Quick-Set infusion sets are affected by this recall, look for the lot number on the product label or on the individual infusion set packaging. The lot number is a seven-digit number (8XXXXXX) located on the left-hand side of the packaging next to the boxed word “ Lot” and under the reference number. According to Medtronic, about 2 percent of the sets are defective, representing about 60,000 out of the total lot of 3 million infusion sets.

If you have experienced any adverse effects as a result of these or other Medtronic insulin pump products, they invite reports at any time at 1-800-345-8139.

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