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
Broken door assemblies on the hospira/abbott acclaim encore infusion pumps. if the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. if the door cannot be closed, the pump cannot be used which can
result in a delay in therapy.
조치
URGENT MEDICAL DEVICE CORRECTION letters, dated October 31, 2013, were sent to all direct accounts. The letters identified the affected product, as well as the reason for recall, risk to health, and instructions for device users. Users are to inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy by following the provided instructions.
The letter also included instructions for recipients to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions; and complete the attached reply form and return it to the fax number or e-mail address on the form. Customers are to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain additional reply forms if needed. If the devices were further distributed, those customers should be notified and asked to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form.
The letter reminds customers that Hospira is retiring the Acclaim Encore infusion pump and will no longer support them as of December 31, 2014.
Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
제품 설명
Hospira Acclaim Encore Infusion Pump || Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.