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.
This recall is currently active, issued May 21, 2019. It was issued by Dutch Ophthalmic Usa, Inc..
- Company
- Dutch Ophthalmic Usa, Inc.
- Recall Initiated
- May 21, 2019
- Recall Number
- Z-2252-2021
- Quantity
- 16 boxes
- Firm Location
- Exeter, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Distribution
US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Lot / Code Info
Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Root Cause
Under Investigation by firm
Action Taken
Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.