Recall Z-2091-2021— Dutch Ophthalmic USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Dutch Ophthalmic USA, Inc., initiated 2021-02-25, terminated 2021-11-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-25
- Terminated
- 2021-11-05
- Firm location
- Exeter, NH, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.