Baxter Amia Automated Peritoneal Dialysis Cl II

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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Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.