Medtronic MiniMed Paradigm Insulin Infusion Sets: Class I Recall
MedSun: Newsletter #87, August 2013

FDA MedWatch Safety Alert

Recall due to the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm tubing connectors. If insulin or other fluids come in contact with the inside of the tubing connector it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered, resulting in hypoglycemia or hyperglycemia.

Additional Information:

Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall. FDA MedWatch Safety Alert. July 12, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm360663.htm


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