Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum r...

FDA Device Recall #Z-2410-2018 — Class II — March 12, 2018

Recall Summary

Recall Number Z-2410-2018
Classification Class II — Moderate risk
Date Initiated March 12, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ohio Medical Corporation
Location Gurnee, IL
Product Type Devices
Quantity 11 units

Product Description

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 Pattern

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

Lot / Code Information

UDI 08688250002085; Catalog Numbers 8702-1251-908, 8701-1251-901, 8705-1251-907, 8701-1251-908, 8705-1251-901; Lot Number ISU177359; Device Unit Numbers JGGW24156, JGGW24193, JGGW24157, JGGW24161 ,JGGW24167, JGGW24169, JGGW24175, JGGW24188, JGGW24189, JGGW24198, JGGW24160

Other Recalls from Ohio Medical Corporation

Recall # Classification Product Date
Z-1980-2025 Class II GCE HEALTHCARE Zen-O lite, Portable Oxygen Conc... May 8, 2025
Z-0482-2022 Class II Instavac Portable Suction Pump, Constant mode (... Nov 16, 2021
Z-2995-2018 Class II Portable Suction Pump, (a) Style 758010, Model ... Aug 14, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.