Klarity Medical Products LLC 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

On July 31, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers, informing them that vacuum bags may experience product failure wherein the bags fail to maintain an adequate vacuum over a required period of time. The loss of vacuum can lead to treatment inaccuracy due to shift of patient location. Customers were instructed to: 1. Inspect current inventory to locate any affected product. 2. Remove product from service. 3. Destroy and dispose of product (the firm recommended cutting up and disposing with normal trash). Klarity will replace affected bags or reimburse your cost, as you choose. 4. Complete the customer response form to confirm receipt of notice and actions taken. If any questions, please contact: Sherry Angus, Klarity Quality Manager. Ph. 740-788-8107 ext.119, sherry@klaritymedical.com