WASHINGTON, D.C. — B. Braun Medical, in a joint venture with the FDA, announced that the company would voluntarily recall 22 lots of blood administration sets. The recalled sets were distributed across the United States and Canada. The recall initiative succeeds a discovery that determined that some of the devices will leak between the filters and tubing. According to MedTechDive, any leaking from the device could cause a blood infection or delay the administration of treatment. B. Braun Medical proclaimed that the company is unaware of any deaths or serious injuries stemming from the defects in the blood administration sets.
- Braun Medical identified 43,000 Y-Type blood sets called Safeline as well as Outlook Safety Infusion System as potentially defective. B. Braun Medical said that the company manufactured the 22 defective lots from the middle of June 2019 to the end of August 2019. B. Braun Medical designed the devices to assist with blood administration via an intravenous catheter.
- Braun Medical indicated that the company received several complaints but also determined that “internal discrepancies” existed. The company did not describe the internal discrepancies. Instead, B. Braun Medical acknowledged the devices could leak at the joint, which connects the blood set tubing to the blood filters.
The defect could be minimally invasive, or fatal, depending on the situation. B. Braun Medical indicated that a leak could delay treatment because the attending medical professional would have to connect a new device. In the worst-case scenario, the leak could permit microorganisms into the patient’s bloodstream, which might lead to a blood infection and sepsis. Sepsis could kill a person in some instances.
Braun Medical reported that the company asked medical professionals to stop using the recalled devices immediately. The company will repair or replace the recalled medical device without charge.
The FDA is monitoring the situation and has not assigned the recall to a particular Class, which would indicate the urgency of the problem.
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