FDA Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
Tag: FDA recall
All
Latest
All
Latest
FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
All
Latest
Baxter Issues Correction for Novum IQ Infusion Pump Over Underinfusion Risk
The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.
All
Latest
FDA Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
Fresenius Kabi Issues Limited Ivenix LVP Recall
Fresenius Kabi recalled a specific lot of Ivenix LVP Primary Administration Sets due to a defect that could cause uncontrolled flow.
Read More
Baxter Recalls Volara System Parts For Disconnection Issues
Baxter is recalling certain Volara System components due to a disconnection issue that may lead to insufficient ventilation.
Read More
Defibtech Recalls Chest Compression Devices for Malfunction
Defibtech is recalling its RMU-2000 ARM XR Chest Compression Devices due to a motor issue that may cause the device to stop compressions, leading to potential patient injury or death.
Read More
Baxter Recalls Life2000 Ventilator for Battery Charging Issue
Baxter is recalling the Life2000 Ventilator System due to potential battery charging dongle failure, which can prevent or hinder charging.
Read More
Hamilton Issues Software Correction for Hamilton-C6 Ventilator
Hamilton Medical issued a software correction for the Hamilton-C6 ventilator due to a failure to restart ventilation in sensor fail mode.
Read More
FDA Classifies Philips, Baxter, and Zoll Ventilator Recalls as Class I
Three major manufacturers—Philips Respironics, Baxter Healthcare, and Zoll Medical—have issued Class I recalls for their ventilators due to critical issues posing a risk of serious injury or death.
Read More
All
Latest
Medline Recalls Sub-G Endotracheal Tube for Choking Risk
Medline recalled the Sub-G Endotracheal Tube with Subglottic Suction due to risks of detachment, tearing, and potential airway obstruction.
