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Dutch Ophthalmic USA, Inc. recalls Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled
Recalled July 28, 2021 · FDA recall Z-2091-2021 · Dutch Ophthalmic USA
Hazard
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 · FDA Class II
Units
12 US
Sold at
Distribution in US states of IL, IN, MO, PA.
Description
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
Product
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Manufacturer(s)
Dutch Ophthalmic USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →