Smiths Medical Product Malfunctions

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Smiths Medical Recalls Certain Medfusion Pumps for …

https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-issues-may

Smiths Medical is recalling Medfusion 3500 and 4000 Syringe Infusion Pumps for eight software malfunctions that affect different serial numbers and software versions. These malfunctions may cause serious harm or death to patients from under- or over-infusion, or delays in the delivery of critical medications … See more

Smiths Medical Recalls Medfusion 3500 and 4000 …

https://voice.ons.org/news-and-views/smiths-medical-recalls-medfusion-3500-and-4000-syringe-infusion-pumps-for-software

July 21, 2022 On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported Smiths Medical’s recall of its Medfusion 3500 and 4000 syringe infusion pumps …

Smiths Medical warned by FDA for multiple violations

https://www.raps.org/news-and-articles/news-articles/2021/11/smiths-medical-warned-for-multiple-violations-in-f

Smiths Medical warned by FDA for multiple violations Regulatory News | 24 November 2021 | By Joanne S. Eglovitch The US Food and Drug Administration (FDA) …

ICU Medical Product Alerts And Notices - Smiths Medical

https://www.smiths-medical.com/customer-support/alerts-and-notices

Customer Support Smiths Medical Product Alerts And Notices Alerts and Notices For questions pertaining to a specific medical device recall, please click on the links below or …

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe …

https://www.goldenberglaw.com/blog/2022/august/smiths-medical-recalls-medfusion-3500-and-4000-s/

In April 2022, Smiths Medical recalled Medfusion 3500 and 4000 Syringe Infusion Pumps due to software malfunctions that can impact infusion delivery. 118,055 …

Smiths Medical ASD Inc. - 617147 - 10/01/2021 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smiths-medical-asd-inc-617147-10012021

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Smiths Medical ASD, Inc., located at 6000 Nathan …

FDA Provides Update on Smiths Medical’s Recall of Its

https://www.fdanews.com/articles/208698-fda-provides-update-on-smiths-medicals-recall-of-its-medfusion-syringe-infusion-pumps

The malfunctions can lead to under-infusion, over-infusion or delays in the delivery of critical medications to patients, the FDA said. The 118,055 affected products …

Smiths Medical Issues Urgent Recall for CADD Infusion …

https://www.onderlaw.com/blog/smiths-medical-issues-urgent-recall-for-cadd-infusion-systems/

This classification is given when faults within a product can result in serious injury, or even death. In the case of Smiths Medical, thousands of incidents of …

MAUDE Adverse Event Report: SMITHS MEDICAL …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=15321926&pc=JKA

Event Type malfunction Event Description It was reported that the suspect device was defective due to its inability to aspirate: no patient injury was reported. …

Medical Products - Medical Devices | ICU Medical

https://www.smiths-medical.com/en-us/products

ICU Medical offers a range of airway management and therapeutic devices for respiratory care, including tracheostomy tubes and accessories, arterial blood gas systems, …

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