Recalls / —

—#207226

Product

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K230041

Affected lot / code info

UDI/DI 00085412610900, Serial Number 3540772

Why it was recalled

One device was improperly performed testing prior to release from a Service Center.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

US Nationwide distribution in the state of Massachusetts.

Timeline

Recall initiated

2024-03-20

Posted by FDA

2024-05-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #207226. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.