Medical device recalls Moderate risk

Queen Comfort Products lLC recalls COVENA PICC Sleeve

Recall date
August 18, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0187-2022
FDA classification
Class II
Brand / firm
Queen Comfort Products lLC
Sold / distributed
US Nationwide distribution.

Why it was recalled

Marketed without FDA clearance

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

What was recalled

COVENA PICC Sleeve

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