BETHLEHEM PAAugust 28 2019B. Braun Medical Inc. B.Braun initiated a voluntary recall of one lot of Infusomat Space Volumetric Infusion Pump Administration Sets Catalog Number 363032 Lot Number . The recalled administration sets are used to deliver parenteral fluids. B.Braun identified through customer complaints the potential of the infusion
Sep 11 2017 Recall applies to sets manufactured before April 2017 Medtronic is replacing old sets that have a risk of insulin over delivery Medtronic is voluntarily recalling specific lots of pump infusion sets manufactured before April 2017 as a result of reports of over delivery of insulin following an infusion set change check if your sets are
0 ml 300 unit Infusion Sets Medtronic Diabetes provides a variety of infusion sets to fit your needs. The FCA involves Medtronic updating their Instructions for Use IFU to. Paradigm Reservoirs have also been designed with a great deal of
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.
May 01 2012 You are subscribed to Recalls Market Withdrawals and Safety Alerts for U.S. Food Drug Administration FDA . This information has recently been updated and is now available. Diamond Pet Foods Expands Voluntary Recall to Include Diamond Puppy Formula due to Possible Salmonella Contamination 05/01/2012 10 07 AM EDT Diamond Pet Foods is
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
Jul 19 2013 On July 7 2013 the US Food and Drug Administration FDA reclassified Medtronic’s voluntary June recall of Medtronic Minimed Paradigm infusion sets as a class I recall the most serious type of recall . The recall was initiated because the infusion sets have the potential to cause over or under delivery of insulin which could result in low or high
Dec 23 2021 Medtronic Issues Voluntary Recall of Certain Insulin Pump Infusion Sets Sep 13 2017 Some infusion sets may be vulnerable to a blockage that could cause too much insulin to be delivered to patients with diabetes putting them at risk of hypoglycemia.
Alert on voluntary recall and corrective action by Defibtech on semi automatic external defibrillators 15 Apr 2011 Recall of microbial contaminated protective wipes and adhesive removers 02 Mar 2011 Safety alert on ACCU CHEK FlexLink Plus infusion sets 11 Feb 2011 Safety concern on Fraxel re store Dual Laser System 27 Jan 2011
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
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. Holds up to 1.
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
Apr 27 2020 GOLDEN Colo. July 3 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 infusion sets used with the company s BodyGuard infusion pumps that were distributed beginning May 2016 see
FDA ALERTS RECALLS AND BLACK BOX WARNINGS September November 2017 Medtronic announced of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.
Sep 11 2017 Medtronic has initiated a worldwide voluntary recall of specific lots of MiniMed infusion sets used with all models of Medtronic insulin pumps. The company said it has determined that the vent
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
A voluntary recall of Medtronic s Quick set infusion sets used with MiniMed Paradigm insulin pumps because the sets may not allow the insulin pump to vent air pressure properly. This could result in the device delivering too much or too little insulin and may lead to
Jul 31 2017 Medtronic announced a voluntary recall of its diabetes insulin infusion pump last September after patient field reports alerted the manufacturer of a problem. Medtronic determined that a discontinued component within the device was causing the pumps to oversupply insulin. An overabundance of insulin can result in hypoglycemia and can prove fatal.
Jan 22 2022 The voluntary recall was issued over concerns that products may contain benzene a known carcinogen. It involves multiple lots of 32 P G dry shampoo or conditioner spray products in a range of sizes. Procter Gamble issued a voluntary recall after some reports indicated that benzene was been found in certain P G aerosolized spray products.
Sep 11 2017 Medtronic recently announced a voluntary recall of specific lots of MiniMed infusion sets used with their insulin pumps due to potential over delivery of insulin after an infusion set change. According to Medtronic this can be caused by fluid blocking the infusion set membrane during the priming/fill tubing process. Visit this Medtronic page to download
Oct 17 2017 Last month Medtronic announced a voluntary recall/replacement for many of their popular Paradigm infusion devices including the Mio Quick Set and Silhouette. Interestingly the problem is not with the tubing or the infusion set itself it is with the connector that attaches the tubing to the insulin reservoir.
Mar 19 2009 FDA Medwatch Alert Medtronic Paradigm Quick Set Infusion Sets. Medtronic Inc. and FDA notified healthcare professionals and patients of a recall of Quick set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets
Jul 13 2018 Medtronic Paradigm insulin pumps are used by diabetics to keep their insulin levels stable but when these pumps malfunction dangerous injuries can result. As a result an Urgent Medical Device Recall has been issued. What are Medtronic Paradigm Pumps Medtronic Paradigm insulin pumps are intended to deliver specific amounts of insulin to insulin
Oct 18 2021 That family of insulin pumps and infusion sets has been the subject of a handful of serious recalls since Medtronic put down 3.7 billion to snap them up in 2001.
Apr 27 2020 CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets April 27 2020 / in Recalls from FDA / by Heather Davis. CME America a wholly owned subsidiary of BD Becton Dickinson and Company a leading global medical technology company today issued the following update
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