Recall Z-2410-2018 ยท KDP Regulator, Vacuum
Ohio Medical Corporation
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.
| Date | Mar 12, 2018 |
| Status | Terminated |
| Reason | Final quality control testing was not completed before the devices were distributed.. |
| Root cause | Employee error |
| 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. |
| Quantity | 11 units |
| Distribution | US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.