Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation

Affected Product

The FDA is aware that Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold:

  • Sigma Spectrum Infusion System V6 Platform
    • Product Code: 35700BAX
    • Unique Device Identifier (UDI): 00085412091570
  • Spectrum IQ Infusion System with Dose IQ Safety Software
    • Product Code: 3570009
    • Unique Device Identifier (UDI): 00085412610900
baxter recall

Reason for Early Alert

Baxter Healthcare Corporation recalled the Spectrum infusion pumps due to the potential for missing motor mounting screws, which may have occurred during the servicing process.

Baxter is requesting the return of the affected pumps for inspection and reservicing as applicable. Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy, or delay in therapy, which can result in serious adverse health consequences.

Baxter has reported one serious injury related to this issue.