| Medtronic recalls insulin infusion kits
NEW YORK (Reuters) - Medical device maker Medtronic Inc. said on
Tuesday it is recalling its Quick-set Plus infusion sets used by
diabetics because of problems that can interrupt insulin flow and
cause serious consequences including death.
The company said patients should exchange any unused Quick-set
Plus infusion sets for replacements.
Medtronic said that the problems that led to the recall have resulted
in a number of serious injuries, including some hospitalizations.
The U.S. Food and Drug Administration (FDA) has classified this
voluntary action as a Class I recall, the company said. The FDA
defines a Class I recall as a situation in which there is a reasonable
probability that the use of the product will cause serious adverse
health consequences or death.
If it is necessary to continue use of the Quick-set Plus while
replacement sets are in transit, Medtronic is recommending frequent
monitoring of blood glucose levels and preparations to treat any
elevated glucose levels with injections, the Minneapolis-headquartered
company said.
The company is also instructing patients to contact their healthcare
professional in the event of excessively high or low glucose levels
or with any questions about their care.
This notification follows a voluntary action undertaken by the
company in March 2004 in response to an increased number of complaints
related to the use of the Quick-set Plus infusion set, which delivers
insulin from an infusion pump to a patient's body.
Patients can call 1-800-646-4633 to exchange unused Quick-set Plus
infusion sets. The recall applies to models MMT-359S6, MMT-359S9,
MMT-359L6, MMT-359L9.
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