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
Injector and syringe, angiographic - Product Code DXT
원인
Some kits have a hole in the packaging which could compromise the sterility of the components.
조치
MEDRAD issued an URGENT MEDICAL DEVICE RECALL letter dated May 17, 2010, to all affected customers. The letter identified the product, the problem, and the action the customer should take.
Customers were instructed to identify the product with the affected lot numbers.
Contact MEDRAD Customer Support at 1-800-633-7231 to make arrangements for the return of the product.
Complete and sign the form attached to the letter and fax it back to MEDRAD at 412-406-0942.
For any questions regarding this recall call (412) 767-2400, ext 6851.
Worldwide Distribution - USA including AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Belgium, China, Columbia, Germany, Denmark, France, Great Britain, Hungary, Ireland, India, Israel, Italy, Mexico, Netherlands, Sweden, and Singapore.
제품 설명
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe || The contents of the package are intended to be used in the delivery of contrast media.