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.
데이터 추가 비고
Pump, Infusion - Product Code FRN
원인
The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25¿c (77¿ f).
조치
Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.
Total number of consignees that received product: 13. Five are wholesale dealers, None are distributors, 8 are retailers. Product has been distributed worldwide, and in the United States: AR, Washington DC, FL, IL, KY, LA, MA, MD, MN, MO, NJ, TX. Also sent to National Institute of Health, Bethesda, MD, (301) 496-4000
제품 설명
GemStar¿ I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271