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U.S. Department of Health and Human Services

Class 2 Device Recall Klarity Vacuum Bags

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  Class 2 Device Recall Klarity Vacuum Bags see related information
Date Initiated by Firm July 31, 2020
Create Date August 24, 2020
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = KLARITY MEDICAL PRODUCTS, LLC
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