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
Hospira shipped the incorrect replaceable battery pack (part no: hsp3566-e10) instead of the correct e09 battery pack (part no. hsp3566-e09) for the symbiq single and dual channel infusers.
조치
The firm, Hospira, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 28, 2013 to its customers. Hospira contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response, tracking, returns, effectiveness checks and destruction of returned product starting on August 28, 2013. The letter described the product, problem and actions to be taken. Customers were instructed to: 1) complete and return the attached reply form via fax to 1-866-470-3291 or e-mail to Hospira2921@stericycle.com, even if you do not currently have the affected batteries; 2) contact Stericycle at 1-877-779-7810 (M-F, 8am - 5pm ET) if they require additional response forms; and, 3) return any affected batteries upon receipt of the new (correct) replacement batteries to Stericycle. Customers are also instructed to forward the recall information to any accounts that they may have shipped the affected batteries to and have them contact Stericycle to recieve a reply form and return label.
For further inquiries, please contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 6, availabel 24 hours a day/7 days per week.
US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
제품 설명
*** 1) SYMBIQ One-Channel Infuser; || *** 2) SYMBIQ Two-Channel Infuser; || *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; || *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. || Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.