Reported Jul 28, 2021 · Terminated
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number:…
Dutch Ophthalmic USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dutch Ophthalmic USA, Inc. · 10 Continental Dr Bldg 1 · Exeter, NH · 03833-7507
Is this the product you have?
- Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use
- in vitreoretinal surgery Product Number
labeled as 1281.B1Dproduct is 1281.B1D06
- Lot codes and dates
- Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
- Amount recalled
- 12 US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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