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Dutch Ophthalmic USA Recalls
3 recalls on record · July 28, 2021 to August 18, 2021 · Medical Devices
August 18, 2021Medical DevicesFDA
Dutch Ophthalmic USA, Inc. recalls The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Pr
Hazard: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
July 28, 2021Medical DevicesFDA
Dutch Ophthalmic USA, Inc. recalls Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Hazard: Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
July 28, 2021Medical DevicesFDA
Dutch Ophthalmic USA, Inc. recalls Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled
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