Dutch Ophthalmic USA, Inc. Recall 88153
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
Dutch Ophthalmic USA, Inc. Recall 88153 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2091-2021 |
| Event ID | 88153 |
| Event 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 |
| Product Type | Devices |
| Distribution | Distribution in US states of IL, IN, MO, PA. |
| Quantity | 12 US |
| Recall Reason | 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 |
| Device Classification | 20210728 |
| Device Code Info | Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757 |
| Center Classification Date | 20210719 |
| Recall Initiation Date | 20210225 |
| Recalling Firm | Dutch Ophthalmic USA, Inc. |
| Initial Notification | Visit |
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