FDA Recall
Terminated
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Recall: Z-3133-2017
·
Initiated September 1, 2017
Recall
- Recall Number
- Z-3133-2017
- Event Number
- 78085
- Firm
- Baxter Healthcare Corp
- FEI Number
- 2314912
- Product Code
- FKX
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- September 1, 2017
- Terminated
- August 27, 2019
- Address
- 1900 Highway 201 N Mountain, Home, AR, 72653-2433
Description
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Reason
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
Action
The firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Distribution
nationwide, Canada
Quantity
164,700 units