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
Cardiovascular Torque Device - Product Code DQX
원인
Five lots of guide catheters and accessory products were processed through ethylene oxide (eto) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for eto sterilization.
조치
Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager:
-Help customer identify aflected product.
- CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below.
- Fax this completed form to (951) 914-3826.
- Return a copy of this completed form with the returned product
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.