FDA Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
Tag: safety
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New RTLS Upgrade Brings Staff Duress Coverage Beyond Hospital Walls
The RTLS platform now enables panic-button protection outdoors—extending support to parking lots, garages, and walking paths.
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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.
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FDA Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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.
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FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
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Gainesville VA Flagged for Recurring Medical Equipment and Safety Issues
Inspectors made seven recommendations following a site visit that revealed persistent issues with equipment management, storage, and cleanliness.
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CDC Investigates Infections Tied to Non-Sterile Ultrasound Gel Use
The CDC is investigating reports of an environmental bacterium linked to the use of ultrasound gel in percutaneous procedures across multiple states.
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Resource-Constrained Healthcare Providers Face Rising Cybersecurity Threats, Report Warns
A new report urges government and industry support to strengthen cybersecurity for resource-constrained healthcare facilities facing escalating cyber threats.
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Opinion: Right to Repair Must Stop Where Patient Safety StartsÂ
A former FDA official argues that medical device repair needs stricter oversight to protect patient safety amid growing right to repair efforts.
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FDA Warns ICU Medical Over Infusion Pump Modifications
The FDA has issued a warning letter to ICU Medical, citing regulatory violations related to unapproved modifications to two of its infusion pumps.
