Reported Aug 18, 2021 · Ongoing
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g ,…
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?
- 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.
- Lot codes and dates
- Lot Number2000401997 Unique Device Identifier (UDI) 08717872021294
- Amount recalled
- 16 boxes
Where it was sold
Why it was recalled
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
This product could cause temporary or reversible health problems — stop using it.
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