Medical device recalls Moderate risk

Ansell Healthcare Products LLC recalls Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Recall date
February 19, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0838-2022
FDA classification
Class II
Brand / firm
Ansell Healthcare Products LLC
Sold / distributed
U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

Why it was recalled

Transport company failed to stop at the border for required FDA inspection.

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

What was recalled

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

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