FDA recall Z-2252-2021

Dutch Ophthalmic USA, Inc. · Class II · 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.

Reason for recall

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

Distribution

US Nationwide Distribution in the states of AL, CA, CO, FL, MI

Key facts

Status
Ongoing
Initiation date
2019-05-21
Report date
2021-08-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Exeter, NH, United States

Primary source

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