Recall Z-0121-2021— Baxter Healthcare Corporation

Name: FDA recall Z-0121-2021
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Class I · Terminated

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-06-30, terminated 2024-04-29. It names one FDA 510(k) clearance: K133801. Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8). Reason: Baxter is updating the device IFU for safety communication regarding cleaning practices..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Terminated
Initiated: 2020-06-30
Terminated: 2024-04-29
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)

Reason for recall

Baxter is updating the device IFU for safety communication regarding cleaning practices.

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