Automated peritoneal dialysis (APD) cycler
This recall has been terminated (originally issued February 16, 2016).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- February 16, 2016
- Terminated
- December 23, 2016
- Recall Number
- Z-1565-2016
- Quantity
- 10 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
Distribution
US Consignee: NY ***Foreign Consignee: Ecuador
Root Cause
Under Investigation by firm
Action Taken
An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter.