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
Kits contain a t connector that may be susceptible to cracking or breaking or leaking. this could cause product leakage or, less likely, patient injury.
조치
The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices.
For questions concerning this recall, please contact the company 1-800-633-7231, select option 2, and indicate that you are calling about the Stellant CT Dual Syringe Kit field correction.
nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA.
제품 설명
Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK