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Medtronic Quick-set Paradigm Mmt-397

Health Canada: Medtronic Recalls Certain Lots Of Paradigm Quick-set Infusion Sets

Health Canada: Medtronic Recalls Certain Lots Of Paradigm Quick-set Infusion Sets

Health Canada: Medtronic Recalls Certain Lots of Paradigm Quick-set Infusion Sets OTTAWA, ONTARIO--(Marketwire - Aug. 6, 2009) - Health Canada is advising Canadians that the company Medtronic has initiated a recall of its Paradigm Quick-set infusion sets with lot numbers beginning with "8" ("Lot 8"). A small percentage of the affected infusion sets may work improperly and may deliver too much or too little insulin, which could cause serious health effects. Medtronic Paradigm Quick-set infusion sets are used by patients with diabetes as part of intensive insulin therapy. An infusion set is a narrow-diameter tube that connects to an insulin pump to deliver insulin to the patient through a needle under the patient's skin. Patients using a Paradigm Quick-set infusion set are advised to check the lot number of their product. (See the instructions provided below.) If the set is from "Lot 8," Medtronic is advising patients to stop using it immediately. Infusion sets from any other lot can be used. Patients can contact Medtronic of Canada directly to arrange the return of any "Lot 8" infusion sets and receive a replacement product. Information about the recall is available on the Medtronic website ( ), or by telephone between 8:30 a.m. and 7:00 p.m. (Eastern time) at 1-800-284-4416. Patients with any questions or concerns regarding a medical device they are using should contact their pharmacist or health care professional. An insulin under-dose could result in high blood sugar (hyperglycemia), while an insulin overdose could lead to low blood sugar (hypoglycemia). Both high and low blood sugar should be recognized and treated promptly to avoid serious complications. The recalled "Lot 8" Quick-set infusion sets were manufactured by Medtronic primarily for distribution in the Un Continue reading >>

Medtronic Minimed Recall

Medtronic Minimed Recall

Medtronic Minimed Infusion Pump Recall Lawyers Medtronic issued a Class I recall of their MiniMed Quick-set Paradigm Infusion Insulin pump on June 29, 2009. Thousands of diabetic patients use this device to monitor their blood glucose levels and assist them in the control of their glucose levels by delivering doses of insulin on a pre-determined schedule. RECALL: Lot 8 Paradigm Quick-Set MiniMed insulin pumps, Reference # MMT-396, MMT-397, MMT-398 and MMT-399. The recall of the Lot 8 Quick-set Infusion set was due to a problem in the manufacturing of the sets where a lubricant clogged the tubes, which prevented the venting of air from the system. The unequal air pressure in the tubes hinders the proper flow of insulin, causing the user to receive too much or too little insulin. Due to the loss of ambient air pressure, with improper venting, a large bolus of insulin could be suddenly injected, resulting in a dramatic and potentially fatal drop in blood glucose levels. This can result in the following symptoms: Severe hypoglycemia can also lead to seizures, stroke, coma and death When the vent clogs it can prevent equalization of the air pressure at the time of priming of the insulin pump. The patient thinks it is properly primed and assumes the insulin is being delivered as scheduled. A diabetic who may have an elevated blood glucose level does not get the required insulin dose. This causes the glucose level to go up significantly and can result in the patient suffering a hyperglycemic event known as ketoacidosis. This is a very serious complication requiring hospitalization until their blood glucose levels come back to normal. This can result in the following symptoms: If severe, it can lead to arrhythmias, stroke, heart attack, blood clots, decreased consciousness, co Continue reading >>

Medtronic Recalls Infusion Sets

Medtronic Recalls Infusion Sets

Medtronic Inc. has voluntarily recalled certain lots of its Quick-set infusion sets used with MiniMed Paradigm insulin pumps. The company said people who have infusion sets with reference numbers MMT-396, MMT-397, MMT-398, and MMT-399 and lot numbers beginning with 8 should stop using them. The lot number is marked both on the product box label and on each infusion set package, below the reference number. More information about how to determine whether you have an affected infusion set is available at Medtronic's diabetes Web site . An infusion set is a thin plastic tube used to deliver insulin from a pump. The user replaces it about every three days. Medtronic said it had found that about 2 percent of the lot 8 infusion setsabout 60,000 in allmay not work properly because they are blocking the insulin pump from venting air pressure as designed. That could result in the pump delivering too much or too little insulin and put the user's health at risk. Medtronic asked customers to return any affected infusion sets to the company and said they would be replaced free of charge. Customers may call Medtronic's information line at 1-800-345-8139. Problems with this or any other diabetes device or medication may be reported to the Food and Drug Administration's MedWatch Program or by calling 1-800-332-1088. Continue reading >>

Medtronic Recalls Certain Lots Of Paradigm Quick-set Infusion Sets

Medtronic Recalls Certain Lots Of Paradigm Quick-set Infusion Sets

Medtronic Recalls Certain Lots of Paradigm Quick-Set Infusion Sets Advisory 2009-126 For immediate release OTTAWA - Health Canada is advising Canadians that the company Medtronic has initiated a recall of its Paradigm Quick-set infusion sets with lot numbers beginning with "8" ("Lot 8"). A small percentage of the affected infusion sets may work improperly and may deliver too much or too little insulin, which could cause serious health effects. Medtronic Paradigm Quick-set infusion sets are used by patients with diabetes as part of intensive insulin therapy. An infusion set is a narrow-diameter tube that connects to an insulin pump to deliver insulin to the patient through a needle under the patient's skin. Patients using a Paradigm Quick-set infusion set are advised to check the lot number of their product. (See the instructions provided below.) If the set is from "Lot 8," Medtronic is advising patients to stop using it immediately. Infusion sets from any other lot can be used. Patients can contact Medtronic of Canada directly to arrange the return of any "Lot 8" infusion sets and receive a replacement product. Information about the recall is available on the Medtronic website, or by telephone between 8:30 a.m. and 7:00 p.m. (Eastern time) at 1-800-284-4416. Patients with any questions or concerns regarding a medical device they are using should contact their pharmacist or health care professional. An insulin under-dose could result in high blood sugar (hyperglycemia), while an insulin overdose could lead to low blood sugar (hypoglycemia). Both high and low blood sugar should be recognized and treated promptly to avoid serious complications. The recalled "Lot 8" Quick-set infusion sets were manufactured by Medtronic primarily for distribution in the United States. Limit Continue reading >>

Minimed Quick-set Infusion Sets

Minimed Quick-set Infusion Sets

MiniMed Quick-set : Comfort and ease MiniMed Quick-set is a popular MiniMed infusion set, combining great comfort and ease of use. Its soft cannula, hypoallergenic tape and ease of insertion with the Quick-Serter device, even in hard-to-reach areas, makes it a great choice for children and adults of average to large build. It is recommended to order infusion sets direct from the NDSS , if you are eligible. Soft cannula of 6mm or 9mm, available in various tubing lengths. Quick-serter insertion device for one-handed 90 insertion. The Quick-set infusion set provides the convenience of a disconnect at the infusion site and a pre-attached adhesive for a discreet, low profile design. Available in either 6mm or 9 mm soft cannula. Works with Quick-serter to provide optimal insertion. All MiniMed infusion sets tubing and reservoirs are designed with a unique MiniMed connection for a more secure insulin delivery. For a better insulin absorption, and to help avoid insulin degradation and infusion set occlusion, you should change your infusion regularly. It is recommended to change your Quick-set infusion set every 48 to 72 hours. MiniMed Quick-set Infusion Set 9mm Cannula, 80cm Tubing (10/box) MiniMed Quick-set Infusion Set 6mm Cannula, 80cm Tubing (10/box) MiniMed Quick-set Infusion Set 9mm Cannula, 110cm Tubing (10/box) MiniMed Quick-set Infusion Set 9mm Cannula, 60cm Tubing (10/box) MiniMed Quick-set Infusion Set 6mm Cannula, 110cm Tubing (10/box) MiniMed Quick-set Infusion Set 6mm Cannula, 60cm Tubing (10/box) Continue reading >>

Solara Medical Supplies

Solara Medical Supplies

Flexible Spending Account (FSA) Eligible Products? This product is FSA Approved which means that is typically eligible for purchase using a Flexible Spending Account. FSA coverage can vary from plan to plan, and your individual employer ultimately determines which products and services are eligible for coverage. Please refer to your employer or plan for the exact details of your flexible spending account before using it. The Quick-set provides the convenience of a disconnect at the infusion site and a pre-attached adhesive for a discreet, low profile design. The Quick-set offers the option of a 6mm soft cannula for leaner bodies or a 9mm soft cannula for most everyone else that is inserted at a 90-degree angle. The Safe Needle Disposal System of the Quick-set helps prevent "accidental stickings" when disposing of the introducer needle in a sharps container. The Quick-set works with the Quick-serter to provide optimal insertion every time! Paradigm Infusion Sets are only compatible with the Paradigm Pump. Rx Required: In the US, this product requires a prescription from your doctor before purchase. This item is restricted by federal law to sale by or on the order of a physician. The price listed is the retail price. For orders billed to your insurance, the actual price is based on the contracted rate. Continue reading >>

Press Release | Newsroom | Medtronic | Medtronic Voluntarily Recalls Specific Lots Of Paradigm Quick-set Infusion Sets In The United States

Press Release | Newsroom | Medtronic | Medtronic Voluntarily Recalls Specific Lots Of Paradigm Quick-set Infusion Sets In The United States

Medtronic Voluntarily Recalls Specific Lots of Paradigm Quick-Set Infusion Sets in the United States Company Is Providing Replacement Infusion Sets to Its Diabetes Customers at No Additional Charge MINNEAPOLIS July 10, 2009 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 lis Continue reading >>

Lawsuit Filed Over Medtronic Minimed Insulin Pump Quick-set Problems

Lawsuit Filed Over Medtronic Minimed Insulin Pump Quick-set Problems

Lawsuit Filed Over Medtronic MiniMed Insulin Pump Quick-Set Problems A group of plaintiffs have filed a lawsuit over recalled Medtronic Quick-Set infusion sets for its MiniMed insulin pump , claiming that the defects in the insulin delivery systems for diabetics caused users to suffer severe injuries and hospitalizations. The Medtronic insulin pump infusion set lawsuit was filed in U.S. District Court in the Southern District of Texas on November 30, on behalf of six plaintiffs; five diabetics who used the Medtronic MiniMed insulin pump and one of the plaintiffs husbands. All five diabetic plaintiffs allege that they were hospitalized after receiving incorrect insulin dosages from Paradigm Quick-Set infusion sets, designed to work with the MiniMed pumps. On June 29, a Medtronic Paradigm Quick-Set recall was issued for about three million disposable infusion sets used with the MiniMed Insulin Pump after it was discovered that some could deliver incorrect doses of insulin. At that time, Medtronic estimated that about 2%, or 60,000 units, of an entire lot of the infusion sets did not vent air pressure properly when delivering an insulin dose. The Quick-set infusion sets are plastic tubes used to infuse a diabetes patient from the MiniMed pump. They are usually replaced after three days. The recalled sets were distributed throughout the U.S., Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas. Affected infusion sets were distributed with a lot number starting with 8 marked on the product box and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The product liability lawsuit cites an FDA warning letter sent to Medtronic just weeks before the recall , which highlighted deficiencies in quality control at its Puerto Ric Continue reading >>

Class 1 Device Recall Paradigm Quickset Infusion Set

Class 1 Device Recall Paradigm Quickset Infusion Set

Class 1 Device Recall PARADIGM QUICKSET INFUSION SET Class 1 Device Recall PARADIGM QUICKSET INFUSION SET Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control. Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered. Medtronic issued an "URGENT MEDICAL DEVICE RECALL" notification letter dated July 6, 2009 to health care professionals, followed by notification letters dated July 7, 2009 to distributors, inactive and active customers. Letters to healthcare professionals and distributors were sent via UPS 2-Day Air with signature confirmation of delivery required. On July 8, 2009 and July 9, 2009, a notification letter, along with replacements sets, were mailed via UPS to active patients or customers (who have ordered since January 2009). The notification letter to patients (inactive customers) who last ordered prior to January 1, 2009 were issued via First Class U.S. Mail. All letters to patients include a preaddressed, postage paid card to confirm that the patient has received the recall notice and to identify whether or not they have unused sets to return. As described in the patient letters, patients have the option to confirm receipt of the notification and to order replacement infusion sets online Continue reading >>

Medtronic Insulin Pump Lawsuit: Recall Of Quick-set Infusions Sets For Minimed Paradigm Insulin Pumps

Medtronic Insulin Pump Lawsuit: Recall Of Quick-set Infusions Sets For Minimed Paradigm Insulin Pumps

Medtronic Insulin Pump Lawsuit: Recall of Quick-Set Infusions Sets for MiniMed Paradigm Insulin Pumps Following the recall of Medtronic infusion pump Quick-set infusion sets issued Friday, the product liability lawyers at Saiontz & Kirk, P.A. are reviewing the potential for lawsuits on behalf of individuals who have suffered severe or fatal injuries as a result of the pumps delivering to much or too little insulin. >>FDA LINK (7/13/2009): Medtronic Paradigm Quick-Set Infusion Set Recall Late in the day Friday, Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an 8. The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin. Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients. Individuals have been told to stop using Lot 8 Quick-set infusion sets and Medtronic is offering to exchange all affected products at no charge. However, for individuals who have been hospitalized or suffered severe injuries as a result of incorrect delivery of insulin from their pump, the recalled units should be saved until after it is determined whether financial compensation may be available through a Medtronic insulin pump l Continue reading >>

Minimed Quick-set<sup></sup> Infusion Sets

Minimed Quick-set Infusion Sets

MiniMed Quick-set : Comfort and easeMiniMed Quick-set is a popular MiniMed infusion set, combining great comfort and ease of use. Its soft cannula, hypoallergenic tape and ease of insertion with the Quick-serter device, even in hard-to-reach areas, makes it a great choice for children and adults of average to large build. Soft cannula of 6mm or 9mm, available in various tubing lengths. Available: QuicK-Serter insertion device for one-handed 90 insertion Usage Information: The Quick-set infusion set provides the convenience of a disconnect at the infusion site and a pre-attached adhesive for a discreet, low profile design. Available in either 6mm or 9 mm soft cannula. Works with Quick-serter to provide optimal insertion. All MiniMed infusion sets tubing and reservoirs are designed with a unique MiniMed connection for a more secure insulin delivery. For a better insulin absorption, and to help avoid insulin degradation and infusion set occlusion, you should change your infusion regularly. It is recommended to change your Quick-set infusion set every 48 to 72 hours. Continue reading >>

Medtronic Recalls Its Quick-set Infusion Sets

Medtronic Recalls Its Quick-set Infusion Sets

Medtronic Recalls Its Quick-set Infusion Sets Minneapolis-based Medtronic Inc. is recalling some lots of its Quick-set infusion sets over concerns that they may cause insulin pumps to deliver too much or too little insulin. The infusion sets in question have the reference numbers MMT-396, MMT-397, MMT-398, and MMT-399, and lot numbers starting with the number 8 printed on their packaging. Customers are asked to return the affected infusion sets to the company. For more information, consumers can call 800-345-8139 or visit Users experiencing adverse reactions can report them to the Food and Drug Administration at The infusion sets, used with the companys MiniMed Paradigm insulin pumps, deliver insulin via a thin plastic tube from the pump to the patient. A malfunction could cause them to deliver too high or to low a dose of insulin, leading to hyperglycemia or hypoglycemia-both dangerous conditions for people with diabetes. However, Medtronic says that there have been no reports of any malfunctions among users of the infusion sets. The recall is a precautionary measure intended to thwart a potential problem. (Editors Note: The message below, distributed by Medtronic, explains the companys recall decision. We are publishing it unaltered to assist Medtronic in getting the word out to Quick-set users.) To Customers Previously Using Lot 8 Quick-set* Infusion Sets Please know that we care about your safety thats why Medtronic acted quickly to recall Lot 8 Quick-set infusion sets. We would like to share some background information about this recall, and also describe how clogged vents on an infusion set could affect blood sugar levels. Please know that Medtronic voluntarily initiated this recall it was not triggered by a patient injury report. Medtronic received a report that Continue reading >>

Medtronic Minimed Infusion Pump Recall

Medtronic Minimed Infusion Pump Recall

Medtronic issued a Class I recall of their MiniMed Quick-set Paradigm Infusion Insulin pump on June 29, 2009. Thousands of diabetic patients use this device to monitor their blood glucose levels and assist them in the control of their glucose levels by delivering doses of insulin on a pre-determined schedule. RECALL: Lot 8 Paradigm Quick-Set MiniMedinsulin pumps, Reference numbers:MMT-396, MMT-397, MMT-398 and MMT-399. A.The recall of the Lot 8 Quick-set Infusion set was due to: a problem in the manufacturing of the sets where a lubricant clogged the tubes, which prevented the venting of air from the system The unequal air pressure in the tubes hinders the proper flow of insulin, causing the user to receive too much or too little insulin Q.What are the adverse effects caused by the recalled lots? Due to the loss of ambient air pressure, with improper venting, a large bolus of insulin could be suddenly injected, resulting in a dramatic and potentially fatal drop in blood glucose levels. Severe hypoglycemia can also lead to seizures, stroke, coma and death Scenario 2: Too little insulin is being delivered The second scenario results from clogging of the vent which prevents equalization of the air pressure at the time of priming of the insulin pump. The patient thinks it is properly primed and assumes the insulin is being delivered as scheduled. A diabetic who may have an elevated blood glucose level of, for example 200 or 250, does not get the required insulin dose. This causes the glucose level to go to 400, 500 or even higher. This results in the patient suffering a hyperglycemic event known as ketoacidosis. These patients are admitted to the hospital and many have to be admitted to the Intensive Care Unit until their blood glucose levels come back to normal. If severe Continue reading >>

Important Safety Information On Medtronic Paradigm Quick-set Infusion Sets (models Mmt-396, Mmt-397, Mmt-398 And Mmt-399) - Notice To Hospitals

Important Safety Information On Medtronic Paradigm Quick-set Infusion Sets (models Mmt-396, Mmt-397, Mmt-398 And Mmt-399) - Notice To Hospitals

Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada , you can request alternate formats by contacting us . Important Safety Information on Medtronic Paradigm Quick-set Infusion Sets (Models MMT-396, MMT-397, MMT-398 and MMT-399) - Notice to Hospitals Notice to Hospitals - Health Canada Issued Important Safety Information on Medtronic Paradigm Quick-set Infusion Sets Please distribute to the relevant Departments of Pharmacy and Endocrinology, Diabetic Education Units, other Departments as required, and other involved professional staff. Please also post this Notice in your institution. Subject: Medtronic Paradigm Quick-set Infusion Sets - Recall on lot 8 (Models MMT-396, MMT-397, MMT-398 and MMT-399) Medtronic of Canada is recalling Paradigm Quick-set infusion sets that have lot numbers starting with the number . These infusion sets are intended for the subcutaneous infusion of insulin from Medtronic MiniMed Paradigm insulin infusion pumps. Quick-set infusion sets were primarily manufactured for distribution in the United States, but limited quantities of these sets were also distributed in Canada by various distributors. No other lots or infusion sets are affected by this recall. It has been identified that a small percentage of Quick-set infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could poten Continue reading >>

Mmt-397 Quick-set Paradigm Infusion Set 10/box

Mmt-397 Quick-set Paradigm Infusion Set 10/box

QUICK-SET PARADIGM INFUSION SET 23/9MM 10/BOX (1 MIS EA) PLEASE NOTE: THIS PRODUCT REQUIRES A DOCTORS PRESCRIPTION. .single_add_to_cart_button{background-color:red !important;} Package Contains: MMT-397 Quick-set 9mm Cannula / 23 Tubing (10/box) Length of cannula:9 mm Soft Cannula (25 gauge) The Quick-set provides the convenience of a disconnect at the infusion site and a pre-attached adhesive for a discreet, low profile design. The Quick-set offers the option of a 6mm soft cannula for leaner bodies or a 9mm soft cannula for most everyone else that is inserted at a 90-degree angle. The Safe Needle Disposal System of the Quick-set prevent accidental stickings when disposing of the introducer needle in a sharps container. Works with the Quick-serter to provide optimal insertion every time! Mfg #: MMT-397 ASIN B00286H6LU Mfg: MINIMED PLEASE FAX ALL PRESCRIPTIONS TO 866-769-9294, email to: [email protected] , OR drag and drop into the form below. IF WE DO NOT RECEIVE THIS YOUR ORDER WILL BE CANCELLED** Continue reading >>

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