Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
Tag: FDA recall
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FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
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Baxter Issues Alert to Solution Sets Users for Assembly Issue
Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.
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Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
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.
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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.
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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.
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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.
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Abbott Recalls HeartMate 3 LVAS for Leakage Issue
Abbott is recalling the HeartMate 3 LVAS due to issues with blood leakage and air entrapment during implantation.
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TruAsset Integrates with Equiptrack for FDA Recalls
TruAsset has integrated with Equiptrack to enhance the efficiency of processing FDA recalls and streamline patient safety processes.
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OptumHealth Recalls Nimbus II Plus Infusion Pumps
OptumHealth Care Solutions is recalling Nimbus II Plus infusion pumps due to multiple failure modes, following an InfuTronix recall.
