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Terminated

Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

FDA Recall Z-3133-2017 · Posted None

Recalling FirmBaxter Healthcare Corp
Recall StatusTerminated
Product CodeFKX
Date Initiated2017-09-01
Date Terminated2019-08-27
Product Quantity164,700 units

Reason for Recall

The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.

Firm Action

The firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

Root Cause

Equipment maintenance

Distribution Pattern

nationwide, Canada

Official Source

View FDA Recall →

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

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