Home / Recalls / Ohio Medical Corporation / Z-2410-2018

Z-2410-2018 Class II Terminated

Recalled by Ohio Medical Corporation — Gurnee, IL

Recall Details

Product Type
Devices
Report Date
July 18, 2018
Initiation Date
March 12, 2018
Termination Date
July 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

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 by Ohio Medical Corporation

  • Z-1980-2025 Class II — GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S (May 8, 2025)
  • Z-0482-2022 Class II — Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and In (November 16, 2021)
  • Z-2995-2018 Class II — Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; ( (August 14, 2018)