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Terminated

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.

FDA Recall Z-2410-2018 · Posted None

Recalling FirmOhio Medical Corporation
Recall StatusTerminated
Product CodeKDP
Date Initiated2018-03-12
Date Terminated2020-07-16
Product Quantity11 units

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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