Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Category: Recalls
Recalls
Latest
Recalls
Latest
Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
Recalls
Latest
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.
Recalls
Latest
Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
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.
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Philips Respironics Updates Use Instructions for Certain BiPAP DevicesÂ
Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.
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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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BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
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SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
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BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues
Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.
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Recalls
Latest
Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits
AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.
