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U.S. Department of Health and Human Services

Class 2 Device Recall Sharesource Connectivity Platform for Use with the Amia Automated PD System

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  Class 2 Device Recall Sharesource Connectivity Platform for Use with the Amia Automated PD System see related information
Date Initiated by Firm June 30, 2021
Create Date August 02, 2021
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-2173-2021
Recall Event ID 88219
510(K)Number K151525  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Sharesource Connectivity Platform for Use with the Amia Automated PD System
Code Information Product Code 5C9400, UDI: 45413765565692, 55413765565699
Recalling Firm/
Manufacturer		 BAXTER HEALTHCARE CORPORATION
25212 W Il Route 120
Round Lake IL 60073-9799
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified its consignees by letter on 06/30/2021. The letter explained the issue with the instructions for use, specifically, That the AMIA Sharesource User Guide describes the function of the UF (ultrafiltration) Limit setting as the ending criteria of the cycler's Extra Last Drain Mode. Baxter will be sending a Follow-Up communication once the AMIA Sharesource User Guide has been updated on the portal.
Quantity in Commerce 1 unit
Distribution Worldwide distribution - US Nationwide distribution and the country of Japan.
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 = FKX and Original Applicant = DEKA RESEARCH AND DEVELOPMENT
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