Report a Medical Device Product Quality Issue
Our Product Complaint and Support team is dedicated to our company's core values built upon a foundation of caring for life. We are available to assist you in fully addressing any concerns in a knowledgeable, effective and timely manner. To make the process as easy as possible, we provide the following services:
- Personal attention to each individual inquiry
- Dedicated associate per product line
- Various methods for reporting product quality issues such as: email, fax, phone, online reporting site
- Investigation letters upon request
- E-Receipts acknowledging the current status of the complaint, if an investigation letter is requested
- Customer satisfaction surveys
- Shipping materials and labels provided for sample return upon request
Important: If reaction or injury has occurred, please seek medical assistance immediately. Please report the reaction or injury to Fresenius Kabi as soon as posible at 1-800-933-6925.
If you wish to report a product quality issue with a Fresenius Kabi product, please contact us at:
Online Product Performance Site
When reporting online, please note you will need to request a User ID.
Online Report Site Training Resources
For more information about submitting a performance report online, please watch the following tutorial: How to Submit a Report
Fax or Email
When submitting a complaint via email or fax, please complete and attach the appropriate form below:
|Fenwal Bioflex RC BPU||COM.TEC Therapeutic Plasma Exchange (TPE)|
|Amicus Mononuclear Cell (MNC)||Amicus Therapeutics (TPE/RBCX)|
|Plasmapheresis||4R2215 Code for Plasmapheresis|
Sample Return Packaging Instructions
For information on how to return samples associated with a complaint, download the Instructions for Packaging sheet.