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
Set, Blood Transfusion - Product Code BRZ
원인
Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
조치
Hospira sent product recall letters dated 9/29/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possibility of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lots, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
Nationwide, including Puerto Rico, and internationally to Australia, Mexico, Canada, Taiwan and Saudi Arabia.
제품 설명
LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Prepierced Injection Site, Prepierced Secondary Port and Option-Lok for use with Plum Series Infusers; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11664-03