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

___________________________________

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.