PMBS, LLC recalls The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Recall date

January 13, 2016

Source

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

Recall number

Z-1266-2016

FDA classification

Class II

Brand / firm

PMBS, LLC

Sold / distributed

FL, GA, MN, NY, OH, OR SC, and TN

Why it was recalled

Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)