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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
-
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