Product Recalls: Quick-set infusion sets used with insulin pumps

Recalls: infusion sets for diabetes patients

The following recall has been announced:

—Medtronic Inc. is recalling certain lots of Quick-set infusion sets, which are used to deliver insulin from an insulin pump to a diabetes patient. The product, which requires a prescription, may not allow the insulin pump to vent air pressure properly and this could result in the device delivering too much or too little insulin, possibly leading to serious injury or death. The Minneapolis company said it has not heard of any reported incidents involving the recalled product.

An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient. The recalled products are used with MiniMed Paradigm insulin pumps. Affected infusion sets have reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 and lot numbers starting with the number 8 printed on the product’s packaging. The recalled Quick-set infusion sets were distributed in the United States and in a small number of other countries in limited numbers.

Customers are asked to return the affected infusion sets to the company. For more information, consumers can call 800-345-8139 or visit www.medtronicdiabetes.com/lot8. Adverse reactions can be reported to the Food and Drug Administration at www.fda.gov/medwatch.

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