FDA-Device2021-07-28Class II
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.
Hazard
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
Sold states
Distribution in US states of IL, IN, MO, PA.
Affected count
12 US
Manufactured in
10 Continental Dr Bldg 1, N/A, Exeter, NH, United States
Products
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2021Don't want to check this manually?
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