Z-2410-2018 Class II Terminated
FDA device recall Z-2410-2018 was initiated by Ohio Medical Corporation on March 12, 2018 and is designated Class II. Reason for recall: Final quality control testing was not completed before the devices were distributed.. The recall status is terminated (terminated July 16, 2020). Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- March 12, 2018
- Termination Date
- July 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
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..
Distribution Pattern
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
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