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Homechoice Automated PD System and Homechoice Pro Automated PD System (2017-07-10)
- Starting date:
- July 10, 2017
- Posting date:
- August 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals
- Identification number:
- RA-64130
Affected Products
- Homechoice Automated PD System
- Homechoice Pro Automated PD System
Reason
Baxter Corporation has been made aware that users may not be following the instructions in the operator's manual and incorrectly opening disposable set packaging while setting up their peritoneal dialysis (PD) therapy, damaging the cassettes for the Homechoice or Homechoice Pro System. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region, and the cycler may deliver air into the patient.
Affected products
A. Homechoice Automated PD System
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
- 5C4471
- 5C4471R
Companies
- Manufacturer
-
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield
60015
Illinois
UNITED STATES
B. Homechoice Pro Automated PD System
Lot or serial number
More than 1000 numbers, contact manufacturer
Model or catalog number
- 5C8310
- 5C8310P
- 5C8310PE
- 5C8310R
Companies
- Manufacturer
-
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield
60015
Illinois
UNITED STATES