FDA-Device2020-09-02Class II
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
Klarity Medical Products LLC
Hazard
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
Affected count
111 units
Manufactured in
600 Industrial Pkwy, N/A, Heath, OH, United States
Products
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2881-2020Don't want to check this manually?
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