Military blood transfuion set recall is serious

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 use…

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House committee investigates $70M federal contract for AutoMedx ventilators

The AutoMedx SAVe II+ ventilator (Image from AutoMedx)

A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19.

The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee on Oversight and Reform. Soon after this contract was signed, officials at the Department of Health and Human Services (HHS) reportedly concluded that the SAVe II ventilator model was inadequate to treat coronavirus patients, a news release from the committee says.

Get the full story on our sister site, Medical Design & Outsourcing.

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