| Class 2 Device Recall Adelante Breezway | |
Date Initiated by Firm | October 05, 2016 |
Create Date | December 19, 2016 |
Recall Status1 |
Terminated 3 on July 26, 2019 |
Recall Number | Z-0794-2017 |
Recall Event ID |
75785 |
510(K)Number | K101497 K122958 |
Product Classification |
Introducer, catheter - Product Code DYB
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Product | OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044
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: C1-12152 Exp. November 30, 2018, C1-09518 Exp. December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018 |
Recalling Firm/ Manufacturer |
Oscor, Inc. 3816 Desoto Blvd Palm Harbor FL 34683-1618
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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 | 991 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = DYB
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