# FDA recall Z-2252-2021

> **Dutch Ophthalmic USA, Inc.** · Class II · device recall initiated 2019-05-21.

## 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

- **Recall number:** Z-2252-2021
- **Recalling firm:** Dutch Ophthalmic USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-05-21
- **Report date:** 2021-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Exeter, NH, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2252-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2252-2021. Source: US FDA. Licensed CC0.

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