Too Much or Too Little Insulin May Be Delivered With Some 'Quick-Set' Infusion Sets
WebMD Health News
Reviewed By Louise Chang, MD
July 10, 2009 -- Medtronic Inc. is voluntarily recalling Lot 8 of its Quick-set infusion sets, which deliver insulin from MiniMed Paradigm insulin pumps to diabetes patients.
The reason for the recall: Some of those infusion sets don't work properly and could lead to dangerous insulin doses.
"Patients should discontinue using 'Lot 8' Quick-set infusion sets," states a Medtronic news release. The lot number is on the product box and on each infusion set package. The affected lot numbers all start with 8, followed by other numbers.
Medtronic says it recently learned that about 2% of the "Lot 8" Quick-set infusion sets may not allow the insulin pump to vent air pressure properly. "This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death," states Medtronic, noting that 2% of Lot 8 is about 60,000 infusion sets out of an estimated 3 million infusion sets that customers currently have.
Medtronic asks customers to return the affected infusion sets to the company, and will provide replacement Quick-set infusion sets at no additional charge. Medtronic is mailing packages via UPS to all customers affected by the recall in stages.
Medtronic says the "Lot 8" Quick-set infusion sets were distributed in the U.S. and "very limited quantities" were also sent to the Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey, and the U.K..
For more information on the recall, visit Medtronic's web site or call Medtronic's information line anytime at 800-345-8139.
SOURCES: News release, Medtronic. Medtronic: "'Lot 8' Quick-set Infusion Sets."
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