Klarity Medical Products LLC recalls Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage…

Recall date

July 31, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2881-2020

FDA classification

Class II

Brand / firm

Klarity Medical Products LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.

Why it was recalled

Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.