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Infusion Set Recall

Diane Fennell

July 10, 2009

Medtronic has voluntarily recalled Quick-set infusion sets that have lot numbers beginning with the number 8. A small percentage of these infusion sets, which are used with MiniMed Paradigm insulin pumps, may not work properly.

Approximately 2% of the infusion sets in Lot 8, representing roughly 60,000 sets in total, may not allow the insulin pump to vent properly (venting allows pressure in the insulin pump reservoir to equalize with the pressure of the surrounding air). If the vent does not work properly, too much or too little insulin could be delivered, potentially resulting in dangerously high or low blood glucose levels.

The lot number for the infusion sets is located both on the box label and on the individual infusion set packages. Only sets in Lot 8 with the model numbers MMT-396, MMT-397, MMT-398, and MMT-399 are affected.

People who have a Quick-set infusion set from the affected lot are advised to stop using the set immediately and to switch to an unaffected infusion set or to an injection regimen. They are additionally urged to contact Medtronic at this Web site or by calling (800) 345-8139. Unused infusion sets can be returned to the company with a prepaid return label to be replaced.

For more information about the recall, see Medtronic’s letter to customers.



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