Dutch Ophthalmic USA, Inc. Recall 88162
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.
Dutch Ophthalmic USA, Inc. Recall 88162 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2252-2021 |
| Event ID | 88162 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide Distribution in the states of AL, CA, CO, FL, MI |
| Quantity | 16 boxes |
| Recall Reason | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line |
| Device Classification | 20210818 |
| Device Code Info | Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294 |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20190521 |
| Recalling Firm | Dutch Ophthalmic USA, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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