Recall Z-0348-2025— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-10-02. It names one FDA 510(k) clearance: K230041. Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. Reason: The door on the Spectrum IQ Infusion pump may not be able to fully close..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-02
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason for recall
The door on the Spectrum IQ Infusion pump may not be able to fully close.
Data sourced from openFDA. This site is unofficial and independent of the FDA.