Dutch Ophthalmic USA, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Dutch Ophthalmic USA, Inc.
Lot Codes / Batch Numbers
Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Products Sold
Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Dutch Ophthalmic USA, Inc. is recalling The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy due to Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Recommended Action
Per FDA guidance
Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026