Sharesource Connectivity Platform for Use with the Amia Automated PD System
Summary
The FDA issued a Class II for Sharesource Connectivity Platform for Use with the Amia Automated PD System by BAXTER HEALTHCARE CORPORATION. Reason: Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly d.
Details
Source
Device Recall
External ID
Z-2173-2021
Action Date
2021-08-11
Status
Terminated
Category
device
Product Description
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Lot/Code Info: Product Code 5C9400, UDI: 45413765565692, 55413765565699
Quantity Affected: 1 unit
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.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-30
Company
Round Lake, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BAXTER HEALTHCARE CORPORATION has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BAXTER HEALTHCARE CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BAXTER HEALTHCARE CORPORATION have FDA actions?
BAXTER HEALTHCARE CORPORATION has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2173-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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