Recalls / —

—#208943

Product

Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K230022

Affected lot / code info

Product Code: 35700BAX2. Serial Number: 2158913.

Why it was recalled

Improperly performed testing prior to release

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US Nationwide distribution in the state of Florida.

Timeline

Recall initiated

2024-06-14

Posted by FDA

2024-08-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #208943. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.