Disposable Replacement Backflush Brush Needles recall: Labeling Error
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is…
Why was Disposable Replacement Backflush Brush Needles 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
- Product
- Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is…
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- Quantity
- 12 US
- Distribution
- Distribution in US states of IL, IN, MO, PA.
- Recall date
- July 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)