Device 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.
Z-2410-2018
Product summary
- Event
- Event 80294
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-2410-2018
Official wording
Reason: Final quality control testing was not completed before the devices were distributed..
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
Distribution pattern: US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Derived failure modes
-
Unknown
Final quality control testing was not completed before the devices were distributed..