Sep 11 2017 Medtronic NYSE MDT said today that it’s recalling some of the infusion sets used with its insulin pumps due to problems with a discontinued component.. The Fridley Minn. based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill tubing.
The global voluntary recall of Medtronic’s diabetes infusion sets includes all models of Medtronic MiniMed insulin pumps. The period of time for the recall includes devices manufactured before April 2017. This recall will affect thousands of devices already being used by patients in Kentucky and across the United States.
Jul 18 2019 FRANKLIN LAKES N.J. July 18 2019 /PRNewswire/ BD Becton Dickinson and Company NYSE BDX a leading global medical technology company today provided an update on two voluntary recalls related to certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 and certain model codes and lot numbers of
Sep 15 2017 Medtronic is voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps having become aware of recent reports of potential over delivery of insulin shortly after an infusion set change. An investigation
Jan 16 2018 RTTNews Medtronic plc MDT announced a voluntary recall of specific lots of infusion sets used with all models of its insulin pumps related to a certain discontinued component in these infusion sets.
Jan 20 2017 Read Dexcom recalls G4 and G5 CGMs. Customers can return any unused MiniMed Pro set infusion sets for either replacement Pro set infusion sets or a different model of Medtronic infusion sets. It should be noted however that this is not an official FDA recall. This infusion set issue was first reported by Diabetes Mine.
Sep 12 2017 Medtronic plc.MDT has initiated a voluntary product recall of specific series of infusion sets used with all models of Medtronic insulin pumps. Shares of the company registered a 0.57 drop to
Dec 31 2019 For instance Medtronic announced a voluntary recall of diabetes infusion sets on September 10 2017. Medtronic determined through a recent report from various healthcare professionals patients and through a root cause analysis shows that the infusion sets may be susceptible to being blocked by fluid during the process of priming/fill tubing.
Sep 11 2017 Medtronic plc announced a voluntary recall of specific lots of infusion sets used with all models of its insulin pumps related to a certain discontinued component in these infusion sets.The company noted that a component the vent membrane may be susceptible to being blocked by fluid during the process of priming/fill tubing which can lead to potential over
Nov 21 2019 September 2017 Voluntary Recall of Diabetes Infusion Sets November 2019 FDA Class 1 Recall on MiniMed Models 630G and 670G Who Qualifies to File a Claim Anyone who has used a Medtronic Insulin Pump that has been recalled may qualify to file a claim. Similarly anyone who has used these insulin pumps and has experienced side effects
Jul 07 2009 URGENT MEDICAL DEVICE RECALL Medtronic Diabetes is voluntarily recalling Quick set infusion sets that have lot numbers starting with the number 8 . The lot number for example 8XXXXXX is clearly marked on both the product box label and on each individual infusion set package. These
Sep 11 2017 Medtronic is recalling specific lots of MiniMed infusion sets after learning of the risk of insulin overdelivery. The global voluntary
Sep 11 2017 Medtronic Announces Voluntary Recall of Diabetes Infusion Sets DUBLINSeptember 11 2017Medtronic plc NYSE MDT announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps.
Jul 19 2019 Becton Dickinson and Company BD has provided update on two voluntary recalls related to certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 and certain model codes and lot numbers of the Alaris Pump Infusion Sets used with the Alaris Pump Model 8100. Image BD provides update on voluntary recalls of Alaris
Jan 06 2022 Nostrum Laboratories Inc. announced on January 4 that it is voluntarily recalling one lot of its Metformin HCl Extended Release Tablets USP 750 mg. The medication is designed to improve blood glucose control in adults with type 2 diabetes when used alongside a healthy diet and exercise.The affected product is packaged in 100 tablet bottles has the NDC of
Jul 08 2020 PRNewswire/CME America a wholly owned subsidiary of BD Becton Dickinson and Company announced a voluntary recall for all CME America BodyGuard Infusion System Administration Sets
Jul 20 2017 Medtronic PLC Issues Insulin Infusion Set Recall Amid Hypoglycemia Fears. Medtronic PLC a medical device company is based in Ireland and one of the largest medical device manufacturers in the world issue a recall for infusion sets used with its insulin pumps in September 2017.Medtronic issued a voluntary recall for particular groups of infusion sets
Sep 12 2017 The Department of Health DH today September 12 received notification from medical device manufacturer Medtronic Hong Kong Medical Limited Medtronic on its voluntary recall of specific lots of MiniMed Infusion Sets due to a potential safety concern.
CarePro Home Medical has been made aware of the voluntary recall of Philips Respironics CPAP and Bi Level PAP machines. Philips Respironics has determined these steps should be taken immediately by current CPAP and Bi Level PAP users 1. Discontinue use of your device and work with your physician to determine the most appropriate options for
Jun 06 2020 Medtronic plc NYSE MDT announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps.
Sep 11 2017 The voluntary recall of infusion sets is not expected to impact Diabetes Group revenue growth in the second quarter or the full fiscal year. The majority of the cost is expected to be incurred in the second quarter and will depend on a variety of factors including the amount of unused sets that patients ultimately return which is difficult
program an infusion to be delayed for up to 120 minutes or until a specific timeframe up to 23 hours and 59 minutes. With a delayed infusion the system assumes another infusion is running to keep the IV line ready until the delayed infusion initiates. A delayed infusion does not revert to KVO at the end of the infusion.
8mL or 3mL reservoirs can be used in the MiniMed 640G Custom made for Medtronic MiniMed 640G MiniMed Paradigm 5 and 7 Series Insulin Pumps Can be used with all MiniMed infusion sets If your Total Daily Dose of Insulin Basal insulin plus typical meal time Bolus insulin is less than 48 units you may want to consider using the 1.
Jul 03 2020 As part of CME America’s commitment to quality following the previously announced recall April 27 2020 of the BodyGuard Infusion Pump Systems the company conducted additional flow rate accuracy testing.This testing revealed that some infusion sets do not meet the ±5 delivery accuracy for the system or the ±13 accuracy identified in the
Aug 08 2020 The additional testing noted some sets do not meet the ±5 delivery accuracy level of the system or the ±13 accuracy level identified in the earlier recall notification. Over infusion or under infusion could cause harm to patient. For Queries on this Device Recall
Background Improved insulin infusion set survival and faster insulin action are important issues for pump users and for the development of an artificial pancreas. The current recommendation is to change infusion sets every 3 days. Our objectives were to determine the effect of lipohypertrophy LH on infusion set survival and continuous glucose monitoring
voluntary Recall for Product Correction for the above mentioned devices. As part of Medtronic’s product quality monitoring process we identified that certain MiniMed Sure T infusion sets had a slight increase of reported cases where the steel needle broke during use. In a small number of these reported cases the needle break led to