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 investigation of the medrad intego indicates that the inner diameter of the saline tubing is out of
specification and may result in the system failing to position the dose correctly
during extraction, potentially leading to a low measurement of the extracted dose or
to a higher dose being extracted. the occluded sas tubing may impair the priming
function and prompt an rp prime fail.
조치
Bayer Healthcare sent an "Urgent Medical Device Field Corrective Action" letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please immediately take the following steps.
Please review your current inventory. Do not use any Source Administration Sets (SAS) with the impacted batch numbers that are included in the index below.
If you have unused affected product, immediately quarantine the product and please call Bayer Customer Service at 1-800-633-7231 to receive a Returned Goods Authorization (RGA) number and return the product immediately to Bayer accordingly.
Please complete the response form and fax it to Bayer at 1-412-406-0942 or e-mail to randiproductrecalls@bayer.com, whether or not you have
impacted product.
To provide you with new product, please submit a new product order.
Please note that due to limited new inventory, there may be a delay in fulfillment.
New batches of SAS are currently being shipped and lead times will be dependent on available supply until inventory returns to normal levels.
We appreciate your cooperation and sincerely regret any inconvenience. We are committed to providing effective products and service to support your patient care. If you have questions, please contact our customer support team at 1-800-633-7231.
Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.
제품 설명
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.