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 pump may shut-off prematurely during battery operation without providing adequate response time when 'e320' service warning message appears.
조치
On 5/18/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the recall.
List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump; List No. 12618-04 Plum A+3 I.V. Infusion Pump; List No. 12348-04 Plum A+3 I.V. Infusion Pump. List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04; 12348-04; 12348-04; 12391-13; 12391-1312391-1 12618-04. All serial numbers of the above list numbered product are included in this correction.
Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.
제품 설명
Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; || Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; || Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; || Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. || Product is manufactured and distributed by || Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA