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
Symbiq infusers have the potential to experience a white screen during titration of a keep vein open (kvo) delivery. this can allow the clinician to select the "next" button prior to completion of the programming. if this error occurs, a delay in therapy could occur and potentially result in significant injury.
조치
Hospira sent an Urgent Device Field Correction notice dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the steps provided in the letter while Hospira is developing a software change. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to contact Stericycle at 1-888-201-9332.
For questions regarding this recall call 224-212-4892.
Worldwide Distribution - US (nationwide) and Canada
제품 설명
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. || The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.