Class 2 Device Recall Baxter Spectrum IQ

• Date Initiated by Firm: October 02, 2024
• Date Posted: November 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0348-2025
• Recall Event ID: 95505
• 510(K)Number: K230041
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
• Code Information: 00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The door on the Spectrum IQ Infusion pump may not be able to fully close.
• FDA Determined Cause: Process control
• Action: Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.
• Quantity in Commerce: 8 units
• Distribution: GA, ID
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN