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U.S. Department of Health and Human Services

Class 2 Device Recall Adelante Breezway

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  Class 2 Device Recall Adelante Breezway see related information
Date Initiated by Firm October 05, 2016
Create Date December 19, 2016
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-0797-2017
Recall Event ID 75785
510(K)Number K101497  K122958  
Product Classification Introducer, catheter - Product Code DYB
Product OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM
D84CM Catalog # AB081047
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Code Information Lot #'s: C1-09372 Exp. November 5, 2017, C1-10142 Exp. April 22, 2018 and OR-04728 Exp. October 21, 2018
Recalling Firm/
Manufacturer		 Oscor, Inc.
3816 Desoto Blvd
Palm Harbor FL 34683-1618
For Additional Information Contact Customer Service
727-937-2511 Ext. 133
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 11
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Oscor Inc.
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