Home / Recalls / Dutch Ophthalmic USA, Inc. / Z-2091-2021

Z-2091-2021 Class II Terminated

Recalled by Dutch Ophthalmic USA, Inc. — Exeter, NH

Recall Details

Product Type: Devices
Report Date: July 28, 2021
Initiation Date: February 25, 2021
Termination Date: November 5, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12 US

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757