Device 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.
Z-2252-2021
Product summary
- Event
- Event 88162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 boxes
- Official record key
device-enforcement:Z-2252-2021
Official wording
Reason: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Code information: Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Distribution pattern: US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Derived failure modes
-
Unknown
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line