—#98667

Product

GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01 A stand-alone PC application for administration of medications specific to the GemStar Infuser

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K083019
Affected lot / code info: list 13092-04-01, lot numbers 71-494-G1, 72-613-G1 and 84-832-G1

Why it was recalled

The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Hospira, sent "URGENT DEVICE FIELD CORRECTION" letters dated March 23, 2011 to their customers on the same date. The letter described the product, problem and preventative action to be taken by the customers until the software can be upgraded. The customers were requested to contact Hospira Global Product Safety and Complaints at 1-800-441-4100 to report adverse events, and Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-262-577-6921. For additional information and technical assistance, contact Hospira Advanced knowledge Center at 1-800-241-4002, option 4 (available 24 hours a day/7 days per week).

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore

Timeline

Recall initiated: 2011-03-23
Posted by FDA: 2011-04-15
Terminated: 2016-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.