# FDA recall Z-2410-2018

> **Ohio Medical Corporation** · Class II · device recall initiated 2018-03-12.

## Product

Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU)    Product  Usage:  The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.

## Reason for recall

Final quality control testing was not completed before the devices were distributed..

## Distribution

US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.

## Key facts

- **Recall number:** Z-2410-2018
- **Recalling firm:** Ohio Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-12
- **Report date:** 2018-07-18
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurnee, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2410-2018

## Citation

> AI Analytics. FDA recall Z-2410-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2410-2018. Source: US FDA. Licensed CC0.

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