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Health product recall

Amia Automated Peritoneal Dialysis Set With Cassette (2017-09-06)

Starting date:
September 6, 2017
Posting date:
September 19, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-64528

Affected Products

A. Amia Automated Peritoneal Dialysis Set With Cassette

Reason

Baxter Corporation is issuing a product recall for certain lots of the Amia Automated Peritoneal Dialysis Set with cassette in response to increased customer complaints received for missing red line, patient slow flow, solution slow flow, and inadequate drain alerts. Increased frequency of these alerts could lead to insufficient draining of waste solution, which can be a contributing factor in fluid overload.

Affected products

  1. Amia Automated Peritoneal Dialysis Set With Cassette

Lot or serial number
  • H16H04114
  • H16H09063
  • H16H26034
  • H16H30010
  • H16I02017
  • H16I14103
  • H16I21058
  • H16J05035
  • H16J07015
Model or catalog number

5C5479

Companies
Manufacturer
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield
60015
Illinois
UNITED STATES