Exeter, NH, United States
Dutch Ophthalmic USA, Inc. recalls
3 recalls recorded since 2018, most recently on 14 April 2021. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 April 2021
- Reason
- 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
- Distribution
- Nationwide Distribution in the states of CA, FL, MA, and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2097-2021
- Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Terminated Class II Medical devices
- Recall started
- 25 February 2021
- Terminated
- 5 November 2021
- 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
- Distribution
- Distribution in US states of IL, IN, MO, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2091-2021
- Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Ongoing Class II Medical devices
- Recall started
- 21 May 2019
- Reason
- Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
- Distribution
- US Nationwide Distribution in the states of AL, CA, CO, FL, MI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2252-2021
- The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.