Class 2 Device Recall Klarity Vacuum Bags

• Date Initiated by Firm: July 31, 2020
• Create Date: August 24, 2020
• Recall Status: Terminated on October 19, 2020
• Recall Number: Z-2881-2020
• Recall Event ID: 86146
• 510(K)Number: K132124
• Product Classification: Accelerator, linear, medical - Product Code IYE
• 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.
• Code Information: Lots R7504-30C: 70621Y and 81008X R7504-35BC: 70415V and 71220V R7504-35C: 81008W R7644-32.5BC: 71228S RC7221-25BC: 70502Y and 70621W RC7504-17.5C: 80411A and 80802W
• Recalling Firm/ Manufacturer: Klarity Medical Products LLC; 600 Industrial Pkwy; Heath OH 43056-1528
• For Additional Information Contact: Sherry Angus; 740-788-8107 Ext. 119
• Manufacturer Reason for Recall: Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
• FDA Determined Cause: Component design/selection
• Action: 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
• Quantity in Commerce: 111 units
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE