Sharesource Connectivity Platform for Use with the Amia Automated PD System
This recall has been terminated (originally issued June 30, 2021).
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- June 30, 2021
- Terminated
- April 10, 2024
- Recall Number
- Z-2173-2021
- Quantity
- 1 unit
- Firm Location
- Round Lake, IL
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Product Code 5C9400, UDI: 45413765565692, 55413765565699
Root Cause
Under Investigation by firm
Action Taken
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.