FDA-Device2016-05-04Class II
Automated peritoneal dialysis (APD) cycler
Baxter Healthcare Corp.
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
Sold states
US Consignee: NY ***Foreign Consignee: Ecuador
Affected count
10 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Automated peritoneal dialysis (APD) cycler
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2016Don't want to check this manually?
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