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 clamp may not secure to the iv pole and the pump may slip or fall off. the pump may fall on a person or pull the tubing out of the iv container.
조치
Hospira issued an "Urgent: Device Field Correction" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira Technical Support Operations at 1-800-241-4002.
Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.
제품 설명
Hospira brand Symbiq Two-Channel Infuser, || LIST No. 16027 Symbiq Two-Channel Infuser, || List Number Configurations: || 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, || 16027-27-89/90, 16027-13-25/26,53/54, || Distributed by: Hospira, Inc. Morgan Hill, CA