FDA-Device2021-08-18Class II

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.
Hazard

Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

Sold states
US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Affected count
16 boxes
Manufactured in
10 Continental Dr Bldg 1, N/A, Exeter, NH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2252-2021

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