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 gemstar infusion pump may not receive direct current (dc) power from the power supply. in one instance, smoke was observed and the gemstar pump was operating on battery power while connected to the 3 volt dc power supply.
조치
An URGENT MEDICAL DEVICE CORRECTION letter dated February 3, 2014 was sent to all direct accounts. The letter included specific instructions for how to handle and use the power supplies so as to minimize the chance of any device failures. There were additional instructions for customers to: 1) Inform potential users in their organization of the product of this notification; 2) Complete the attached reply form and return it to the fax number or e-mail address on the form (even if you do not have any affected product in inventory); 3) If the products were further distributed, their customers should be notified of the recall and asked to contact Stericycle at 888-641-9735 to receive a reply form; and, 4) if a potential user believes that their power supply is damaged for any reason, it should be removed from service and the user should contact Hospira Global Complaints at 800-441-4100 to report the concern.
The letter further notes that there is no need to return fully functional power supplies (unless they malfunction).
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
제품 설명
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.