FDAClass IIJuly 18, 2018

Vacuum Regulator recall

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…

Why was Vacuum Regulator recalled?

Final quality control testing was not completed before the devices were distributed..

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Ohio Medical Corporation
Quantity
11 units
Distribution
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Recall date
July 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls