Health product recall

Amia Automated PD Set With Cassette

Last updated

Summary

Product
Amia Automated PD Set With Cassette
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products Lot or serial number Model or catalog number
Amia Automated PD Set With Cassette H23G14074 H23G15048 H23F27037 H23G07052 H23F24018 H23G16038 H23F29066 H23G11054 H23G17051 H23F28035 5C5479

Issue

Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices.  The affected lots were distributed from 08/01/2023 to 09/26/2023 in Canada. 

Recall Start Date: November 16, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies

Baxter Healthcare Corporation

1 Baxter Parkway, Deerfield, Illinois, United States, 60015

Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Identification number
RA-74669