Medtronic Recalls Some Paradigm Sets Used by Diabetics
Last Updated: 2009-07-10 10:49:03 -0400 (Reuters Health)
* Recalls some lots of sets used with insulin pumps
* Says working with FDA to resolve issues
* To replace recalled sets
CHICAGO (Reuters) - Medtronic Inc said it was recalling specific lots of its Paradigm Quick Set infusion sets that are used with Minimed Paradign insulin pumps because they may not work properly.
The company said on Friday it recently discovered that about 60,000, or 2 percent of the infusion sets of "lot 8", may not allow the insulin pump to vent air pressure properly.
Medtronic said it was working with the Food and Drug Administration to resolve the issue and would replace the recalled infusion sets.
An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every 3 days.
Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8."
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