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FDA Class I Recall Issued for Medtronic Minimed Paradigm Insulin Infusion Sets

FDA Class I Recall Issued for Medtronic Minimed Paradigm Insulin Infusion Sets

It goes without saying that flawed medications are often very dangerous for consumers. Earlier this month, a large drug product manufacturer, Fresenius Kabi, recalled four lots of Benztropine Mesylate Injections due to the risk of tiny clear particulates existing in the glass vials, posing a safety risk to consumers. This week, another large drug manufacturer issued a recall for a defective medical product. Medtronic is recalling Minimed Paradigm insulin infusion sets due to defective pumps that lead to a potential insulin over- or under-dosage.

The infusion sets are used by diabetes mellitus patients who administer insulin to moderate blood glucose levels, according to a notice issued by the FDA. If insulin or other fluids come into contact with the inside of the tubing connector in the insulin pump, then it could become a potential safety hazard for the patient. If fluid gets inside the tubing, it could affect the pump’s priming process, and possibly lead to the administration of too much or too little insulin. If a patient receives the wrong amount of insulin, the patient could develop severe conditions, such as hypoglycemia or hyperglycemia.

Early in June, Medtronic issued an urgent notification to medical professionals, patients and distributors of the infusion sets to inform them of the potential for the product to result in unwanted dosage levels of insulin. The recall applies to all infusion sets by Medtronic that are for use with the Medtronic Paradigm family infusion pumps.

A post-priming drip of insulin from the tip of the infusion set cannula is an indication of a defective product, and means that the connector vents might not be working as needed, according to Medscape. Patients are instructed to stop using the product if it seems unusual and call 1-888-204-7616 for assistance with the pump.

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