Class 2 Device Recall Baxter Spectrum IQ

• Date Initiated by Firm: March 20, 2024
• Date Posted: May 03, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1775-2024
• Recall Event ID: 94446
• 510(K)Number: K230041
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter Spectrum IQ Infusion Pump, Product Code 3570009
• Code Information: UDI/DI 00085412610900, Serial Number 3540772
• 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: One device was improperly performed testing prior to release from a Service Center.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.
• Quantity in Commerce: 1 pump
• Distribution: US Nationwide distribution in the state of Massachusetts.
• 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