FDA-Device2022-08-03Class II
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Covidien Llc
Hazard
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Sold states
AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
Affected count
33 units
Manufactured in
15 Hampshire St, Mansfield, MA, United States
Products
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2022Don't want to check this manually?
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