FDA recall Z-2881-2020

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-07-31

Report date

2020-09-02

Termination date

2020-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Heath, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2881-2020