The FDA issued three notices identifying warnings sent out by ICU Medical‘s Smiths Medical unit related to infusion pump problems. Smiths Medical warned of issues with some of its CADD-Solis and CADD-Solis VIP ambulatory infusion pumps. The CADD-Solis pump offers utility in hospital or outpatient settings, delivering pain therapies. CADD-Solis VIP pumps are intended for […]
Smiths Medical
Smiths Medical warns on infusion cassette reservoirs in Europe
ICU Medical’s Smiths Medical unit issued an urgent field safety notice in Europe to warn of issues with certain medication cassette reservoirs. Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and […]
ICU Medical’s Smiths Medical is reportedly closing a New Hampshire plant, cutting 220 jobs
ICU Medical’s Smiths Medical unit reportedly plans to close a New Hampshire manufacturing facility that houses about 220 employees. The infusion technology maker plans to close the plant in Keene, New Hampshire, next year, according to the Keene Sentinel. The outlet said VP of Global Marketing, Tom McCall, confirmed the decision to close today after […]
Smiths Medical warns on some infusion pumps
An urgent field safety notice issued in Europe warns of software issues with some CADD-Solis ambulatory infusion pumps made by Smiths Medical. The ICU Medical unit corrected some issues in previous software updates but some problems persist. For starters, according to the communication, the infusion pump may not alarm for an upstream occlusion. This issue […]
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
Smiths Medical issues urgent device correction for some CADD infusion pumps
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 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 […]
