Device recall

Z-2410-2018: Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage…

FDA device recall · Class II · Ohio Medical Corporation

Key facts

Recall number (Z-number) Z-2410-2018
Recall event 80294
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
Recalling firm Ohio Medical Corporation
Recall class Class II
Status Terminated
Termination date Jul 16, 2020
FEI number 1419185

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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