Recall Z-2881-2020— Klarity Medical Products LLC

Name: FDA recall Z-2881-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-31

Class II · Terminated

Class II FDA medical device recall by Klarity Medical Products LLC, initiated 2020-07-31, terminated 2020-10-19. It names one FDA 510(k) clearance: K132124. Product: 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.. Reason: Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times..

Recalling firm: Klarity Medical Products LLC
Classification: Class II
Status: Terminated
Initiated: 2020-07-31
Terminated: 2020-10-19
Firm location: Heath, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K132124 — KLARITY VACUUM BAG, KLARITY MOLD CUSHIONKlarity Medical Products, LLC·cleared 2013-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.