Medical device recalls High risk

Combat Medical Systems, LLC recalls Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration…

Recall date
December 23, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1111-2021
FDA classification
Class I
Brand / firm
Combat Medical Systems, LLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.

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