FDA Recall
Open, Classified
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: Z-2252-2021
·
Initiated May 21, 2019
Recall
- Recall Number
- Z-2252-2021
- Event Number
- 88162
- Firm
- Dutch Ophthalmic USA, Inc.
- FEI Number
- 3007916166
- Product Code
- HQC
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 21, 2019
- Address
- 10 Continental Dr, Bldg 1, Exeter, NH, 03833-7507
Description
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.
Reason
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Action
Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.
Distribution
US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Quantity
16 boxes