The FDA last week announced a Class I recall — the most serious kind — for transfusion sets made by Combat Medical Systems.
Included in the recall was the Valkyrie LTOWB Collection and Administration set, Low Titer Type O Transfusion Set and Low Titer Type O Donor Collection Set and the Fresh Whole Blood Transfusion Set and Fresh Whole Blood Donor Set, according to an FDA notice.
The kits are used by military personnel to get and transfuse donor blood to patients on the battlefield. Each kit has a blood bag with a needle attached and includes other components for screening blood.
Affected devices were distributed between July 1, 2019, and Nov. 30, 2020. The FDA initiated the recall on Dec. 23, 2020, and has since recalled 30,549 devices in the U.S.
Combat Medical is recalling the device because the needle in the blood pack may bend or disconnect from the blood bag. This possible needle damage only occurs during the packaging process before the user received the product, but a user would not be able to identify if the needle is damaged until the pack has been opened for use.
If the needle is bent or disconnected, it could potentially result in bruising or hematoma, as well as delay, change or inability to treat patients by giving needed blood, which could lead to injury or death. So far, there have been four complaints about the issue and zero reports of injury or death.
Users are instructed to remove all affected convenience kits from use and return the affected kit to Combat Medical. Nobody should use any kit with a bent or disconnected needle.