Non-sterile recalled over sterility concerns

Recall date

May 13, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SVS LLC recalls Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to preven…

Recall number

Z-2320-2024

FDA classification

Class II

Brand / firm

SVS LLC

Sold / distributed

US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.

Why it was recalled

Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).

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

What was recalled

Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.