Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

FDA Recall Z-0932-2015 · Posted 2015-01-07

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFKX
Date Initiated2014-04-24
Date Terminated2017-07-21
Product Quantity55 units

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.

Firm Action

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

Distribution Pattern

Nationwide Distribution including GA, MA, NC, NY, PA, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K124018AMIA AUTOMATED PD SYSTEMDeka Research & Development Corp. · 2013-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑