Medical device recalls Moderate risk

Ansell Healthcare Products LLC recalls NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Recall date
August 3, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0097-2024
FDA classification
Class II
Brand / firm
Ansell Healthcare Products LLC
Sold / distributed
Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.

Why it was recalled

Some surgical glove sterile pouches were not completely sealed.

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

What was recalled

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

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