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Recall Observatory FDA recall evidence

Device product

Automated peritoneal dialysis (APD) cycler

Z-1565-2016

February 16, 2016

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 73435
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1565-2016

Official wording

Reason: 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

Code information: N/A

Distribution pattern: US Consignee: NY ***Foreign Consignee: Ecuador

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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