CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (Pts-isu) recalled
Ohio Medical is recalling Vacuum Regulator, Push-T-Set Intermittent Suction Unit (Pts-isu), distributed nationwide in the US. The recall was initiated on 12 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2410-2018
- FDA event ID
- 80294
- Recalling firm
- Ohio Medical, Gurnee, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Mar 2018
- FDA classified
- 10 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Mar 2018 | Recall initiated by company | |
| 10 Jul 2018 | Classified by FDA | +120 days |
| 18 Jul 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Final quality control testing was not completed before the devices were distributed..
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Nationwide FloridaIllinoisIndianaLouisianaMichiganNorth CarolinaTennessee
Questions about this recall
Why was it recalled?
Final quality control testing was not completed before the devices were distributed..
Which lots 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
Where was it sold?
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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