This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Homechoice Pro Automated PD System (2013-10-21)
- Starting date:
- October 21, 2013
- Posting date:
- November 29, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Disease
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36895
Recalled Products
Homechoice Pro Automated PD System
Reason
Baxter is notifying customers of a potential issue with the occluder assembly for specific serial numbers of Homechoice Pro devices. The occluder may contain sharp edges and/or may separate from the back plate, which may cause the occluder assembly to fail resulting in an unrecoverable slow flow/no flow alarm or an unrecoverable system error. The device will fail in a safe position and prevent solution from being delivered to the patient, but patient will also not be able to perform/complete therapy.
Affected products
Homechoice Pro Automated PD System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
5C8310P
Companies
- Manufacturer
-
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield
60015
Illinois
UNITED STATES