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, […]
Recalls
BD warns on certain infusion systems due to potential leakage
BD (NYSE:BD) issued a notice in Europe to remove specific lots of its Connecta Stopcock and Nexiva with Connecta from use. In May, the Franklin Lakes, New Jersey-based company issued a product removal field safety notice and has since identified further lots which may also exhibit a reported defect. According to a notice dated July […]
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 […]
Medtronic issues voluntary recall for certain In.Pact drug-coated balloon catheters
Medtronic (NYSE:MDT) announced today that it voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV balloon catheters. The company initiated the recent recall of the paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. According to the company, approximately 6,000 In.Pact Admiral […]
Boston Scientific warns on some SpaceOAR systems
Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems. Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers enhanced […]
Tandem Diabetes warns on some t:slim X2 insulin pumps
Tandem Diabetes Care (Nasdaq:TNDM) issued an urgent field safety notice in Europe for its t:slim X2 insulin pump with Basal-IQ technology. The notice, dated February 2022, alerts users of Tandem’s insulin pump with a software version of 6.3.0.1 that there may be a potential safety risk when using the pump within its normal specifications. Tandem’s […]
Fresenius Kabi recalls sodium acetate injection due to presence of particulate matter
Fresenius Kabi USA announced today that it initiated the voluntary recall of seven lots of its sodium acetate injection. Lake Zurich, Illinois-based Fresenius Kabi recalled the USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or […]
Baxter warns of alarm malfunction on some infusion pumps
Baxter (NYSE:BAX) announced today that it has issued an urgent safety communication regarding upstream occlusion alarms for certain infusion pumps. Deerfield, Illinois–based Baxter warned that incorrect administration set setup and/or the incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication. The problem might occur without the users receiving alerts […]
Medtronic Diabetes receives FDA warning over quality system requirement inadequacies
Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]