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Terminated

Automated peritoneal dialysis (APD) cycler

FDA Recall Z-1565-2016 · Posted None

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFKX
Date Initiated2016-02-16
Date Terminated2016-12-23
Product Quantity10 units

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Consignee: NY ***Foreign Consignee: Ecuador

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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