Combat Medical Systems, LLC recalls Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfu…

Recall date

December 23, 2020

Source

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

Recall number

Z-1113-2021

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

Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.