HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.
FDA device recall Z-0564-03 · posted 2003-02-21 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
- Action taken
- Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines. The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.
- Root cause
- Other
- Status
- Terminated
- Product code
- FKX
- Distribution
- Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.
- Date initiated
- 2002-12-23
- Date posted
- 2003-02-21
- Date terminated
- 2007-12-11
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 (K012988) | Baxter Healthcare Corp | 2001-12-05 |