—#184464

Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042121
Affected lot / code info: Product Code 35700BAX, GTIN 00085412091587

Why it was recalled

There is a potential software error during programming.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.

Timeline

Recall initiated: 2020-11-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.