Ohio Medical Vacuum Regulator recallZ-2410-2018 · Ohio Medical Corporation · initiated Mar 12, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ohio Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Final quality control testing was not completed before the devices were distributed..
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2410-2018
- Status
- Terminated
- Initiated by the company
- Mar 12, 2018
- Recalling firm
- Ohio Medical Corporation
- Quantity
- 11 units
- Product code
- KDP
- Distribution
- US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ohio Medical Vacuum Regulator PISAOhio Medical, LLC · Regulator, Vacuum1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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