B. Braun Medical has recalled a single lot of its Infusomat Space Volumetric Infusion Pump administration sets, citing risks of fluid path contamination and air embolization.
Customers complained of sets leaking or disconnecting at the bonded joint between the tubing and injection site, a defect that could lead to a bloodstream infection if the fluid path became contaminated. Additionally, potentially fatal air embolization could occur if the fluid path was open.
The company pulled a total of 2,580 device units manufactured on Sept. 21, 2018 and distributed between Nov. 23, 2018 and March 20. It said that of the 17 complaints it received, none reported a serious injury or patient death.