B. Braun Medical is recalling 22 lots of blood administration sets from the U.S. and Canada, FDA said Tuesday.
The recall follows the discovery that some devices suffer from leakage between the blood filters and tubing.
Leakage could delay treatment or lead to blood infections but B. Braun is yet to learn of serious injuries or deaths resulting from the fault.
The recall affects 43,000 Y-type Blood Sets, including Safeline and Outlook Safety Infusion System products, that B. Braun manufactured between mid-June and late-August. Healthcare professionals use the devices to administer blood to patients through an intravenous catheter.
Based on complaints and "internal discrepancies," B. Braun has concluded that the devices are prone to leakage from the joint that connects blood filters to blood set tubing. At best, the leak would force the healthcare professional to connect a new blood administration set, delaying treatment. At worst, the leak could allow microorganisms to enter the bloodstream and infect the patient, causing sepsis.
Given those risks, B. Braun wants organizations in possession of the recalled units to stop using them immediately and contact its customer support department. B. Braun will arrange the return of the devices and offer to replace or refund them.
FDA knows about the recall and shared details on its website, but is yet to assign it to a risk class. B. Braun initiated the recall on Nov. 15 and published a statement about it online five days later.
News of the recall comes months after B. Braun identified a risk of leakage in another device, namely its Infusomat Space volumetric infusion pump administration set. That recall, which FDA categorized as a Class 1 event, stemmed from the discovery that in some devices the bonded joint between the tubing and injection site was prone to leaking.
To date, FDA has classified 10 B. Braun recalls this year. All bar one of the recalls relates to the risk of damage to the filter membrane in spinal epidural anesthesia kits. The other recall involved the leaky infusion pump administration set.
With most of the year gone, B. Braun is on track to initiate far fewer recalls than in 2018, when FDA shared details of 106 product withdrawals. Most of the recalls related to the risk of leakage from devices used in the administration of fluids.