Combat Medical Systems, LLC recalls Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collect…

Recall date

December 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1110-2021

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 Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.