After Zicam, Nestle cookie dough, Anti-smoking drugs, another episode of recall by Food and Drug Administration (FDA) has come into limelight. This time FDA’s recall axe has fallen neither on a drug nor a food product, but on an insulin infusion device used with insulin pump. This device is manufactured by one of the largest medical device company, Medtronic, Inc, a Minneapolis based company. Customers are being asked to discontinue using “Lot 8” Quick-set infusion sets and return the affected sets to the company. The affected “Lot 8” Quick-set infusion sets may result in delivering too much or too little insulin that can be fatal for patients. However, no injuries have been reported so far with the potential malfunction.
The Quick-set infusion sets involved in this recall have reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers that start with the number “8.
An insulin infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetic patient, and is typically replaced by the patient in every three days.
Why is Medtronic recalling “Lot 8” Quick-set infusion sets?
Medtronic says that they recently identified that approximately 2% (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) of “Lot 8” Quick-set infusion sets used with MiniMed Paradigm insulin pumps may not work properly. Some of these sets may not vent air pressure correctly, thereby can cause delivery of too much or too little insulin in the body that can lead to serious injury and even death to patients.
How do I locate the lot number “8” on my “Lot 8” Quick-set infusion set?
The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual package level.
What does customer do with the defective product?
Medtronic is providing customers...
with replacement of Quick-set infusion sets at no additional charge. Patients with questions about the recall, refund, return and replacement can get more information at http://www.medtronicdiabetes.com/lot8.
Which countries outside the United States are affected by this recall?
Most of the sets were distributed in the U.S., although limited quantities of the affected products also have been distributed to 12 other countries, including Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey and the UK.
Does “Lot 8” recall affect all Quick-set infusion sets?
This is not a first time Medtronic was given warning by FDA, Medtronic was issued a dangerous device warning by FDA, Class I recall for a series of its defective infusion pumps including Synchromed drug-infusion pump and its MiniMed insulin pump. According to the FDA a Class I recall is issued when there is a reasonable probability that use of the product will cause injury or death.
It is highly important that medical device and other healthcare related industries should pay utmost attention towards the quality of their products to mitigate fatal risks to the patients. I think, in addition to steps taken by the FDA and healthcare industries, it is responsibility of each of us to be aware of such issues and should keep ourselves update with basic and current health issues and news. Internet media has eased accessibility of health information through online health web portals, blogs, etc and we should tap into these resources.