Recall Z-2252-2021— Dutch Ophthalmic USA, Inc.

Name: FDA recall Z-2252-2021
Creator: U.S. Food and Drug Administration
Published: 2019-05-21

Class II · Ongoing

Class II FDA medical device recall by Dutch Ophthalmic USA, Inc., initiated 2019-05-21. It names one FDA 510(k) clearance: K190875. 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: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line.

Recalling firm: Dutch Ophthalmic USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-05-21
Firm location: Exeter, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K190875 — EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)D.O.R.C. Dutch Ophthalmic Research Center (International)·cleared 2019-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.