Medical device recalls Moderate risk

ROi CPS LLC recalls Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

Recall date
April 20, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2265-2020
FDA classification
Class II
Brand / firm
ROi CPS LLC
Sold / distributed
US nationwide distribution in the states of MO, AR and OK.

Why it was recalled

Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.

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

What was recalled

Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

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