Recall Z-2173-2021— BAXTER HEALTHCARE CORPORATION
Class II · Terminated
Class II FDA medical device recall by BAXTER HEALTHCARE CORPORATION, initiated 2021-06-30, terminated 2024-04-10. It names one FDA 510(k) clearance: K151525. Product: Sharesource Connectivity Platform for Use with the Amia Automated PD System. Reason: 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..
- Recalling firm
- BAXTER HEALTHCARE CORPORATION
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-30
- Terminated
- 2024-04-10
- Firm location
- Round Lake, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sharesource Connectivity Platform for Use with the Amia Automated PD System
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.