Company:Baxter Healthcare Corp
Date of Enforcement Report 9/20/2017
ClasslI:
PRODUCT
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Recall Number Z-3133-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Mountain Home, AR on 9/1/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
164,700 units
DISTRIBUTION
Nationwide and Canada
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