Recall Z-2173-2021
Baxter Healthcare Corporation · initiated June 30, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Codes / lots: Product Code 5C9400, UDI: 45413765565692, 55413765565699
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: 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.
Details
- Recall number
- Z-2173-2021
- Initiated
- June 30, 2021
- Terminated
- April 10, 2024
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Recalling firm
- Baxter Healthcare Corporation, Round Lake, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2174-2021 Class II | Kaguya Automated Peritoneal Dialysis SystemBaxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA… | 06/30/2021Terminated |