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Homechoice and Homechoice Pro Automated PD Systems (2013-10-10)
- Starting date:
- October 10, 2013
- Posting date:
- November 25, 2013
- 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, Hospitals
- Identification number:
- RA-36861
Recalled products
- Homechoice Automated PD System
- Homechoice Pro Automated PD System
Reason
For dialysis patients with ascites using Homechoice and Homechoice Pro devices with software version 10.4, because the device will attempt to drain the patient to empty during the initial drain, there is an increased risk of hypotension and compromised hemodyamic status.
Affected products
A. Homechoice Automated PD System
Lot or serial number
More than 1000 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
- 5C8310R
Companies
- Manufacturer
-
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield
60015
Illinois
UNITED STATES