Z-2252-2021Class II

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack...

Name: Z-2252-2021 The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack...
Creator: Dutch Ophthalmic USA, Inc.
Published: 2019-05-21
License: https://open.fda.gov/license/

Dutch Ophthalmic USA, Inc. / initiated 2019-05-21 / Open, Classified / root cause: labeling and UDI

FDA source

Dutch Ophthalmic USA, Inc. began a recall of 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 on 2019-05-21. FDA classified it as Class II and gives the reason as "Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2252-2021
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-21
Posted: 2021-08-12
Recalling firm: Dutch Ophthalmic USA, Inc.
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.
Product code: HQC Unit, Phacofragmentation
Reason for recall: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.
Quantity in commerce: 16 boxes
Distribution: US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Product codes and lots: Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code HQC

K190875Class IIEVA, 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)