FDA recall Z-2410-2018

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-03-12

Report date

2018-07-18

Termination date

2020-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2410-2018