Infusion Pump Recall
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Class 2 Device Recall SIGMA Spectrum Infusion Pump. Recalls Medfusion 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy The FDA has identified this as a Class I recall the most serious.
Epic Smartez Elastomeric Pumps For Infusion Therapy Electronic Products Pumps Medical
Reflecting their widespread use Baxters Sigma Spectrum infusion pumps subject to a Dec.
Infusion pump recall. Food and Drug Administration FDA has classified the recall as Class I the most serious classification of recall. The Food and Drug Administration has classified a recall of about 600 pediatric drug-infusion pumps made by Plymouth-based Smiths Medical as a Class 1 recall meaning that a software problem in the. Intended to be used for the controlled administration.
The infusion pump fails to generate an audible alarm for a critical problem such as an occlusion eg clamped tubing or the presence of air in the infusion tubing. Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Version 8 - Product Usage. 1 recall received 17493 complaints about unplanned shutdowns of the device and 16 reports of serious injuries.
Reason for Recall Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pumps reservoir. BDCareFusion 303 is recalling the Alaris Infusion Pump System due to the following hardware situations. 13 2020 -- One person has died and more than 2000 have been injured by malfunctioning insulin pumps that are now part.
Recall notification - Alaris Pump Infusion Sets BD confirmed that infusion sets affected by this recall have a variation in the wall thickness of the pumping segment and therefore may not be fully occluded by the pump. The recall includes around 774000 units. Smiths Medical ASD Inc.
Food and Drug Administration has classified a recall of around 600 drug-infusion pumps made by Minneapolis-based Smiths Medical as a Class 1 recall the most serious type of recall. Damaged Inter-Unit Interface IUI Connectors Class 1 Recall - Damaged IUI connectors may lead to. What is a Drug-Infusion Pump.
Is recalling certain lots of Alaris System Infusion Pumps due to system and software errors. Thousands of Infusion Pumps Recalled After Several Injuries and a Death On March 6 2020 the US. The infusion pump generates.
Food and Drug Administration announced that it had classified the Becton Dickinson Alaris System infusion pump recall as a Class I recall the agencys most severe recall for medical devices that could cause serious injury or death. Have produced errors that may. Reason for Recall CME America is recalling the BodyGuard Infusion Pump Systems because the pumps may have a slower than expected delivery of medication under-infusion and faster than expected.
Faulty Insulin Pump Blamed for One Death By Aaron Gould Sheinin Feb. Becton Dickinson BD is recalling Alaris Infusion Sets due to the potential for faster than expected delivery of medication over-infusion or an unintended delivery that occurs while the pump is. According to the FDA a variety of Alaris infusion pump models in the series 8000 included in the recall from 2004 to 2019 affecting 774000 units sold in the US.
24x7 Magazine ISMP Identifies Errors with Infusion Pumps as Top Medication Safety Issue Smiths Medical HCA Capital Go Live with Smart Pump Programming at Nine Sites Rigel Medical Offers Free Booklet on Infusion Pump Testing FDA Issues Statement on Baxters Recall of Colleague Infusion Pumps AAMI Foundation Publishes Infusion Therapy Safety Quick Guide. BAX has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. Braun initiated a voluntary recall of one lot of Infusomat Space Volumetric Infusion Pump Administration Sets Catalog Number 363032 Lot Number 0061641410.
This means that the use of these devices may lead to serious injuries or death. No deaths were connected to the issue. Baxter has a serious infusion pump recall October 29 2020 By Chris Newmarker Baxter NYSE.
Becton Dickinson BD CareFusion 303 Inc. Broken elements on Alaris Pump Module platen Class 1 Recall - A.
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