Recall Z-2252-2021
Dutch Ophthalmic USA, Inc. · initiated May 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Reason for recall
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
FDA-determined 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.
Details
- Recall number
- Z-2252-2021
- Initiated
- May 21, 2019
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 16 boxes
- Distribution
- US Nationwide Distribution in the states of AL, CA, CO, FL, MI
- Recalling firm
- Dutch Ophthalmic USA, Inc., Exeter, NH