Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
Tag: class 1 recall
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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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Hamilton Medical Inc. Recalls Ventilators Due to Critical Software Issue
Hamilton Medical Inc. has issued a Class I recall, the most serious category, for Hamilton-C1, C2, C3, and T1 ventilators due to a critical software glitch that can abruptly halt operation after 91 days without restarting.
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Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
FDA Class I Recalls Hit 15-Year High in 2022
Sedgwick released its 2023 Product Recall Index, which detailed why defective and violative products reached a record-breaking high.
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Reworked Philips Ventilators Get Class I Recall for Potential Foam Debris Issues
Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.
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GE HealthCare Recalls Nuclear Medicine Systems
GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two of its mechanisms.
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Smiths Medical Infusion Pump Support Solutions Get FDA Class I Recall
Smiths Medical is recalling certain computerized ambulatory delivery device (CADD) administration sets and medication cassette reservoirs—both of which are intended for use with CADD infusion pumps—for two potential issues.
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LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop
LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.
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Getinge Subsidiary Recalls Intra-Aortic Balloon Pumps Due to Compromised Materials
Getinge is recalling IABP devices due to a compromised intra-aortic balloon causing blood to enter the IABP during therapy.
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Baxter Hillrom Recalls Incontinence Management System Due to RF Interferences
Baxter Hillrom is recalling its incontinence management system following reports that its radio frequency emissions interferes with devices.
