Medical device recalls Moderate risk

Ansell Healthcare Products LLC recalls MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device i…

Recall date
August 19, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0051-2021
FDA classification
Class II
Brand / firm
Ansell Healthcare Products LLC
Sold / distributed
U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.

Why it was recalled

Examination gloves were shipped inadvertently, without to verify barrier integrity.

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

What was recalled

MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.

Get recall alerts

Free email alert whenever Ansell Healthcare Products LLC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Ansell Healthcare Products LLC