Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
FDA device recall Z-0775-2025 · posted 2024-12-27 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Action taken
- Customers were contacted via telephone beginning 11/19/24. Baxter Healthcare is calling to notify you of a potential issue with the Spectrum infusion pump. One of your devices has been identified as released after repair without full testing being performed, which includes flow testing. Baxter is requesting the return of the impacted infusion pump to perform all tests required and confirm that the infusion pump performs as expected. As part of this process, we need to make you aware of the potential hazard associated with flow related issues. Flow issues may cause excessive therapy, free-flow condition, insufficient therapy or interruption of therapy. These may lead to serious adverse health consequences, including permanent injury and death. Send signed form to Global CORP Service Quality Field Actions Global_CORP_Service_Quality_Field_Actions@baxter.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 1 units
- Distribution
- US Nationwide distribution in the states of AL, IN.
- Date initiated
- 2024-11-19
- Date posted
- 2024-12-27
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY (K133801) | Baxter Healthcare Corporation | 2014-05-07 |