Automated peritoneal dialysis (APD) cycler
Reported: May 4, 2016 Initiated: February 16, 2016 #Z-1565-2016
Product Description
Automated peritoneal dialysis (APD) cycler
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
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 10 units
- Distribution
- US Consignee: NY ***Foreign Consignee: Ecuador
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Automated peritoneal dialysis (APD) cycler. Recalled by Baxter Healthcare Corp.. Units affected: 10 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1565-2016.
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