Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system. The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no […]
Smiths Medical
Smiths Medical warns on potential issue with fluid warmers
Smiths Medical announced today that it issued an urgent medical device correction letter regarding its Level 1 Fast Flow fluid warmers. Minneapolis-based Smiths Medical’s Level 1 H-2 pressure chambers used with the Level 1 Fast Flow fluid warmers could potentially impact the pressure exerted onto an IV fluid bag while contained within the pressure chamber, […]
ICU Medical’s Smiths Medical has a Class I infusion pump recall
The FDA has issued a notice classifying a recall of infusion pumps from Smiths Medical as Class I, the most serious kind. Smiths Medical — which was acquired by ICU Medical in January for $2.35 billion — earlier this month issued a warning in Europe for the same reason: eight potential issues with its Medfusion […]
Smiths Medical warns on 8 potential issues with infusion pumps
Smiths Medical issued an urgent field safety notice in Europe regarding its Medfusion 3500 and 4000 infusion pumps. The company issued the letter to notify on eight potential issues with its pumps. The issues include false alarms, unanticipated depleted battery alarms and abnormal circuit board behavior causing internal clock system failure. Additionally, issues with intermittent […]
ICU Medical beats The Street in Q1
ICU Medical (Nasdaq:ICUI) reported first-quarter results that came in ahead of the consensus earnings per share forecast. The San Clemente, California-based company yesterday evening posted losses of $38.1 million, or $1.61 per share, on sales of $543.1 million for the three months ended March 31, 2022, for a bottom-line slide into the red on sales […]
ICU Medical beats The Street in Q4, posts full-year guidance
ICU Medical (NASDAQ:ICUI) shares rose today on fourth-quarter results that came in ahead of the consensus forecast. The San Clemente, California-based company posted profits of $19.9 million, or 91¢ per share, on sales of $340.5 million for the three months ended Dec. 31, 2021, for a 23.8% bottom-line slide on sales growth of 6.3%. Get the […]
ICU Medical’s Smiths Medical acquisition remains on track
ICU Medical (NASDAQ:ICUI) is a step closer to acquiring Smiths Medical after clearing a shareholders vote at Smiths’ British parent company, the Smiths Group. Almost all of the nearly 327 million Smiths Group shareholders voting on November 17 approved the $2.35 billion buy. Get the full story on our sister site Medical Tubing + Extrusion.
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
Smiths Medical partners with Ivenix on infusion management suite
Smiths Medical announced today that it partnered with Ivenix on infusion management. Minneapolis-based Smiths Medical will invest an unspecified amount in the long-term partnership to “revolutionize” infusion management and improve patient safety while meeting the needs of healthcare providers, according to a news release. Boston-based Ivenix develops what it touts as “the first and only […]
Smiths Medical recalls Medfusion 4000 due to issue with software update
Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s […]
