Z-2410-2018Class II

Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU)

Name: Z-2410-2018 Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU)
Creator: Ohio Medical Corporation
Published: 2018-03-12
License: https://open.fda.gov/license/

Ohio Medical LLC / initiated 2018-03-12 / Terminated / root cause: manufacturing process

FDA source

Ohio Medical Corporation began a recall of 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... on 2018-03-12. FDA classified it as Class II and gives the reason as "Final quality control testing was not completed before the devices were distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2410-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-07-10
Terminated: 2020-07-16
Recalling firm: Ohio Medical LLC
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.
Product code: KDP Regulator, Vacuum
Reason for recall: Final quality control testing was not completed before the devices were distributed..
Root cause tag: manufacturing process
FDA 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 in commerce: 11 units
Distribution: US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2410-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2410-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10

Product code KDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)