FDA Recall
Terminated
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.
Recall: Z-2410-2018
·
Initiated March 12, 2018
Recall
- Recall Number
- Z-2410-2018
- Event Number
- 80294
- Firm
- Ohio Medical Corporation
- FEI Number
- 1419185
- Product Code
- KDP
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 12, 2018
- Terminated
- July 16, 2020
- Address
- 1111 Lakeside Dr, Gurnee, IL, 60031-2489
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
Final quality control testing was not completed before the devices were distributed..
Action
Ohio Medical notified customers via phone call on about 03/12/2018. The notification included identification of the devices distributed to that customer, explanation that due to the need to the missed additional testing they were removing the devices, and providing a replacement until the testing can be completed.
Distribution
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Quantity
11 units