Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
FDA Recall Z-2530-2024 · Posted 2024-08-07
Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-06-14
Product Quantity1 unit
Reason for Recall
Improperly performed testing prior to release
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the state of Florida.
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.