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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FKX
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