Recalls / —

—#211363

Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K133801

Affected lot / code info

GTIN 00085412091570; Serial Number: 779515

Why it was recalled

Devices were identified as released after repair without full testing being performed, which includes flow testing.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US Nationwide distribution in the states of AL, IN.

Timeline

Recall initiated

2024-11-19

Posted by FDA

2024-12-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #211363. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.