U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
데이터 추가 비고
Pump, infusion - Product Code FRN
원인
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.
조치
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).
Worldwide distribution: USA (nationwide) and countries including: Canada, Chile, Colombia and Singapore
제품 설명
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