Recall Z-0714-2021— Baxter Healthcare Corporation

Name: FDA recall Z-0714-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-23

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-11-23. It names one FDA 510(k) clearance: K133801. Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.. Reason: There is a potential software error during programming..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-11-23
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 8) - Product Usage: intended to be used for the controlled administration of fluids.

Reason for recall

There is a potential software error during programming.

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