Z-2091-2021 Class II Terminated
FDA device recall Z-2091-2021 was initiated by Dutch Ophthalmic USA, Inc. on February 25, 2021 and is designated Class II. 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 The recall status is terminated (terminated November 5, 2021). Affected quantity: 12 US.
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