Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Reported: July 28, 2021 Initiated: February 25, 2021 #Z-2091-2021
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
Details
- Recalling Firm
- Dutch Ophthalmic USA, Inc.
- Units Affected
- 12 US
- Distribution
- Distribution in US states of IL, IN, MO, PA.
- Location
- Exeter, NH
Frequently Asked Questions
What product was recalled? ▼
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06. Recalled by Dutch Ophthalmic USA, Inc.. Units affected: 12 US.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2091-2021.
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