Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritone
FDA device recall Z-0932-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
- Action taken
- Baxter sent an IMPORTANT PRODUCT INFORMATION letter dated April 24, 2014 to all affected customers. The peritoneal dialysis provider consignees were instructed to: 1) complete the enclosed customer reply form and return it to Baxter; and, 2) contact Baxter Technical Services at 800-553-6898 should a System Event 01179 occur. Baxter Technical Services is available 24 hours a day, 7 days a week. Clinical questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00 PM CT). General questions regarding the Import Product Information letter can be direct to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CT). For questions regarding this recall call 800-422-9837.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 55 units
- Distribution
- Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
- Date initiated
- 2014-04-24
- Date posted
- 2015-01-07
- Date terminated
- 2017-07-21
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMIA AUTOMATED PD SYSTEM (K124018) | Deka Research & Development Corp. | 2013-06-14 |