SIGMA Spectrum Infusion Pump (Baxter) - Testing Concern (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code: 35700BAX2. Serial Number: 2158913.
Products Sold
Product Code: 35700BAX2. Serial Number: 2158913.
Baxter Healthcare Corporation is recalling Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 due to Improperly performed testing prior to release. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Improperly performed testing prior to release
Recommended Action
Per FDA guidance
The impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026