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
Packaging may exhibit open seals - sterility compromised.
조치
Medrad sent a " Urgent Medical Device Recall letter" dated October 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The customer was instructed if they have any of the affected product lot, please contact MEDRAD customer support to make arrangements for the return of the product. Call 1 -800-633-7231, select option 5, then select option 1. Indicate that you are calling about the affected syringe kit recall.
Complete and sign the attached response form and fax it back to MEDRAD at
(412) 406-0942.
Please complete and fax this form even if you do not have any of the referenced product so we can maintain proper accountability for all syring kits that have been shipped.
Nationwide Distribution -- including the States of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, VS, WA, WV, and WI.
제품 설명
Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. || Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.