Recall Z-1487-2021— Baxter Healthcare Corporation

Name: FDA recall Z-1487-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-19

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-03-19, terminated 2022-07-15. It names one FDA 510(k) clearance: K173084. Product: Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.. Reason: Potentially defective component in the AC power adapter which may fail over time..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Terminated: 2022-07-15
Firm location: Medina, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K173084 — Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation·cleared 2018-05-11

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

Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.

Reason for recall

Potentially defective component in the AC power adapter which may fail over time.

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