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Baxter Healthcare Corp. recalls Automated peritoneal dialysis (APD) cycler
Recalled May 4, 2016 · FDA recall Z-1565-2016 · Baxter Healthcare
Hazard
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 · FDA Class II
Units
10 units
Sold at
US Consignee: NY ***Foreign Consignee: Ecuador
Description
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
Product
Automated peritoneal dialysis (APD) cycler
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →