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
Introducer, catheter - Product Code DYB
원인
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
조치
Oscor sent two(2) Product Recall notifications:
-HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable).
Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email RGA@Oscor.com Hours of operations: Monday to Friday from 8:30AM to 5:30PM Eastern Time.
- DISTRIBUTORS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Please pull a list of the hospitals (end user) impacted by the affected lots and retrieve inventory for replacement, if available. Review, complete, sign and return the enclosed Acknowledgement Form (Exhibit A) attached in this letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email RGA@Oscor.com Hours of operation: Monday to Friday from 8:30AM to 5:30PM Eastern Standard Time.
Lot #'s: C1-09714 Exp. February 11, 2018, OR-04657 Exp. April 20, 2018, C1-10900 Exp. July 19, 2018, C1-10899 Exp. July 19, 2018, C1-11048 Exp. August 3, 2018, C1-11729 Exp. October 4, 2018, C1-11729 Exp. October 4, 2018, OR-04729 Exp. October 29, 2018, C1-12233 Exp. December 21, 2018, C1-12234 Exp. December 22, 2018, C1-12234 Exp. December 22, 2018, C1-09062 Exp. June 24, 2017, C1-09062 Exp. June 24, 2017, C1-11047 Exp. August 3, 2018 and C1-12234 Exp. December 22, 2018 2
Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
제품 설명
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 || Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.