Recall Z-1254-2025— Baxter Healthcare Corporation
Class I · Ongoing
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-02-05. It names one FDA 510(k) clearance: K230041. Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. Reason: There is the potential for missing motor mounting screws, which may have occurred during the servicing process..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-02-05
- 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
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Data sourced from openFDA. This site is unofficial and independent of the FDA.