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BAXTER HEALTHCARE CORPORATION Recall 88219

Description: Sharesource Connectivity Platform for Use with the Amia Automated PD System

BAXTER HEALTHCARE CORPORATION Recall 88219 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2173-2021
Event ID88219
Event DescriptionSharesource Connectivity Platform for Use with the Amia Automated PD System
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the country of Japan.
Quantity1 unit
Recall ReasonBaxter 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 cycler s 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.
Device Classification20210811
Device Code InfoProduct Code 5C9400, UDI: 45413765565692, 55413765565699
Center Classification Date20210802
Recall Initiation Date20210630
Recalling FirmBAXTER HEALTHCARE CORPORATION
Initial Notification Letter
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