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.
- Company
- Ohio Medical Corporation
- Recall Initiated
- March 12, 2018
- Terminated
- July 16, 2020
- Recall Number
- Z-2410-2018
- Quantity
- 11 units
- Firm Location
- Gurnee, IL
Reason for Recall
Final quality control testing was not completed before the devices were distributed..
Distribution
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Lot / Code Info
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
Root Cause
Employee error
Action Taken
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.