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Open, Classified

Spectrum IQ Infusion Pump, Product Code 3570009

FDA Recall Z-2415-2025 · Posted 2025-08-22

Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-07-14
Product Quantity6 units

Reason for Recall

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

Firm Action

Customers were contacted via telephone beginning 7/14/25. The included information about the product, the issue and the action to be taken by the customers. Baxter Healthcare is requesting the return of the impacted product to perform all tests required and confirm that the product perform as expected. If you have any questions, phone (Toll Free): 800-422-9837 or 847-948-4770; hours of operation: Monday through Friday from 8:00 am to 5:00 pm CST

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution to states of: AZ, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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