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HOMECHOICE AUTOMATED SYSTEMS (2016-01-13)
- Starting date:
- January 13, 2016
- Posting date:
- January 25, 2016
- 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-56816
Affected Products
- HOMECHOICE AUTOMATED PD SYSTEM
- HOMECHOICE PRO AUTOMATED PD SYSTEM
Reason
In response to complaints that HOMECHOICE devices are excessively noisy, Baxter is updating the HOMECHOICE Patient At-Home Guide to include a discussion of the expected operating sounds during therapy. Customers are advised that if there is a significant change in the sound level or a new, previously unheard sound when using the HOMECHOICE cycler, please contact your doctor and/or nurse or Baxter technical services.
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