Dutch Ophthalmic USA product recalled over labeling errors

Recall date

February 25, 2021

Source

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

Official notice title

Dutch Ophthalmic USA, Inc. recalls Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labele…

Recall number

Z-2091-2021

FDA classification

Class II

Brand / firm

Dutch Ophthalmic USA, Inc.

Sold / distributed

Distribution in US states of IL, IN, MO, PA.

Why it was recalled

Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06

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

What was recalled

Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06