medical Class II Updated 2021-07-28

Dutch Ophthalmic USA, Inc. recalls Disposable Replacement Backflush Brush Needles (23 gauge/0.6

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: IL, IN, MO, PA
Lot/Code Info: Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
View official government recall

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