OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
- Company
- Oscor, Inc.
- Recall Initiated
- October 5, 2016
- Terminated
- July 26, 2019
- Recall Number
- Z-0795-2017
- Quantity
- 76
- Firm Location
- Palm Harbor, FL
Reason for Recall
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Distribution
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
Lot / Code Info
Lot #'s: C1-09374 Exp. November 5, 2017, C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11671 Exp. September 30, 2018, C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018, C1-11672 Exp. September 30, 2018, and C1-09374 Exp. November 5, 2017
Root Cause
Nonconforming Material/Component
Action Taken
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.