Recall Z-0775-2025— Baxter Healthcare Corporation

Name: FDA recall Z-0775-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-19

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-11-19. It names one FDA 510(k) clearance: K133801. Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX. Reason: Devices were identified as released after repair without full testing being performed, which includes flow testing..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-11-19
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K133801 — BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYBaxter Healthcare Corporation·cleared 2014-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.