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 […]
ICU Medical
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 […]
ICU Medical’s Smiths Medical has a major syringe pump recall
The FDA this week said it’s designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency’s most serious level of medical device recall. The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, […]
FDA clears new infusion pump and software from ICU Medical
ICU Medical (Nasdaq:ICUI) announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software. The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024. Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on […]
ICU Medical to close Minnesota facility, cut 81 jobs
ICU Medical (Nasdaq: ICUI) filed with the state of Minnesota to confirm a facility closure and some layoffs. Layoffs continue to impact the medtech industry as companies battle ongoing economic challenges. Over the past year or so, MassDevice has reported on around 18,000 job cuts across the industry. Minnesota’s State Rapid Response Team received a Worker […]
ICU Medical recalls certain infusion pump replacement batteries
The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]
ICU Medical stock slides on mixed Q4, projected 2023 losses
ICU Medical (Nasdaq:ICUI) shares took a hit today on fourth-quarter results that came in mixed compared to the consensus forecast. Shares of ICUI fell 6.2% at $166.70 apiece just after the market opened today. The San Clemente, California-based company posted losses of $15.5 million in the quarter. That amounts to 65¢ per share on sales […]
Research firm names ICU Medical infusion pump ‘top-performing smart pump’
ICU Medical announced today that its Plum 360 smart infusion system received recognition by healthcare research firm KLAS Research. KLAS Research named Plum 360 a “top-performing smart pump” in its “EMR-integrated” and “traditional” categories. It marks the sixth straight year Plum 360 received recognition as a “Best in KLAS” technology. ICU Medical said in a […]
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 […]
