Recall Z-2410-2018— Ohio Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Ohio Medical Corporation, initiated 2018-03-12, terminated 2020-07-16. FDA's recall record names no specific 510(k) clearance for this event. 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: Final quality control testing was not completed before the devices were distributed...
- Recalling firm
- Ohio Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-12
- Terminated
- 2020-07-16
- Firm location
- Gurnee, IL, United States
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..
Data sourced from openFDA. This site is unofficial and independent of the FDA.