The following message appeared on the other forum i am on - not sure if anyone here uses the minimed - but thought it may be of interest. Bev
> > Medtronic Diabetes is voluntarily recalling Quick-set. infusion sets> > that have lot numbers starting with the number "8". These infusion> > sets are used with MiniMed Paradigm. Insulin Pumps. The action was> > taken because of a situation related to the tubing> connector which may> > not allow the insulin pump to vent properly. If the vent> does not work> > properly, this could potentially result in too much or too little> > insulin being delivered and may lead to serious injury or> death. All> > patients who have been shipped "Lot 8" Quick-set infusion sets are> > being instructed to discontinue using them immediately.> >>>>> I have found more information here. Most of these infusion sets were> delivered in the US and only limited quantities were to a small number> of countries outside of the US>>> Medtronic Voluntarily Recalls Specific Lots of Paradigm. Quick-Set.> Infusion Sets in the United States> Medtronic, Inc. (NYSE:MDT) said today that it has initiated a> recall of> specific lots of Quick-set. infusion sets that are used with MiniMed> Paradigm insulin pumps. An infusion set is a thin plastic tube used to> deliver insulin from an insulin pump to a diabetes patient, and is> typically replaced by the patient every three days. Affected infusion> sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with> lot numbers starting with the number 8. Medtronic recently> discovered> that approximately two percent of Lot 8 Quick-set infusion> sets (which> represents approximately 60,000 infusion sets out of an estimated 3> million infusion sets currently with customers) may not work properly.> The affected 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.>> Patients should discontinue using Lot 8 Quick-set infusion sets. The> lot number (for example 8XXXXXX) is clearly marked on both the product> box label, and on each individual infusion set package. Visit the> Medtronic Diabetes website at www.medtronicdiabetes.com/lot8> to view the> labels of Lot 8 Quick-set infusion sets. Customers are> being asked to> return any affected infusion sets to the company. Medtronic> is providing> customers with replacement Quick-set infusion sets at no additional> charge.>> Lot 8 Quick-set infusion sets were distributed in the United States,> and in limited quantities in a small number of countries> outside of the> United States. The list of countries affected by this recall is> available at www.medtronicdiabetes.com/lot8 or by contacting any> Medtronic country office. No other Medtronic devices or infusion sets> are involved in this recall.>> Our commitment to patient safety is our top priority, said Chris O> Connell, president of the Diabetes business unit and senior vice> president at Medtronic. We are focused on ensuring that patients and> clinicians have up-to-date information and access to replacement> infusion sets. We are working closely with the FDA, and our goal is to> make this product exchange as timely and as easy as possible for> patients.>> Adverse Event Reporting>> Product problems should be reported to the Diabetes business at> Medtronic by calling 800-345-8139 at any time. Adverse reactions or> quality problems may also be reported to the FDAs MedWatch Program by> phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at> MedWatch,> HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the> MedWatch website at www.fda.gov/medwatch.>
> > Medtronic Diabetes is voluntarily recalling Quick-set. infusion sets> > that have lot numbers starting with the number "8". These infusion> > sets are used with MiniMed Paradigm. Insulin Pumps. The action was> > taken because of a situation related to the tubing> connector which may> > not allow the insulin pump to vent properly. If the vent> does not work> > properly, this could potentially result in too much or too little> > insulin being delivered and may lead to serious injury or> death. All> > patients who have been shipped "Lot 8" Quick-set infusion sets are> > being instructed to discontinue using them immediately.> >>>>> I have found more information here. Most of these infusion sets were> delivered in the US and only limited quantities were to a small number> of countries outside of the US>>> Medtronic Voluntarily Recalls Specific Lots of Paradigm. Quick-Set.> Infusion Sets in the United States> Medtronic, Inc. (NYSE:MDT) said today that it has initiated a> recall of> specific lots of Quick-set. infusion sets that are used with MiniMed> Paradigm insulin pumps. An infusion set is a thin plastic tube used to> deliver insulin from an insulin pump to a diabetes patient, and is> typically replaced by the patient every three days. Affected infusion> sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with> lot numbers starting with the number 8. Medtronic recently> discovered> that approximately two percent of Lot 8 Quick-set infusion> sets (which> represents approximately 60,000 infusion sets out of an estimated 3> million infusion sets currently with customers) may not work properly.> The affected 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.>> Patients should discontinue using Lot 8 Quick-set infusion sets. The> lot number (for example 8XXXXXX) is clearly marked on both the product> box label, and on each individual infusion set package. Visit the> Medtronic Diabetes website at www.medtronicdiabetes.com/lot8> to view the> labels of Lot 8 Quick-set infusion sets. Customers are> being asked to> return any affected infusion sets to the company. Medtronic> is providing> customers with replacement Quick-set infusion sets at no additional> charge.>> Lot 8 Quick-set infusion sets were distributed in the United States,> and in limited quantities in a small number of countries> outside of the> United States. The list of countries affected by this recall is> available at www.medtronicdiabetes.com/lot8 or by contacting any> Medtronic country office. No other Medtronic devices or infusion sets> are involved in this recall.>> Our commitment to patient safety is our top priority, said Chris O> Connell, president of the Diabetes business unit and senior vice> president at Medtronic. We are focused on ensuring that patients and> clinicians have up-to-date information and access to replacement> infusion sets. We are working closely with the FDA, and our goal is to> make this product exchange as timely and as easy as possible for> patients.>> Adverse Event Reporting>> Product problems should be reported to the Diabetes business at> Medtronic by calling 800-345-8139 at any time. Adverse reactions or> quality problems may also be reported to the FDAs MedWatch Program by> phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at> MedWatch,> HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the> MedWatch website at www.fda.gov/medwatch.>
