| Class 2 Device Recall Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath | |
Date Initiated by Firm | May 22, 2017 |
Create Date | June 14, 2017 |
Recall Status1 |
Terminated 3 on May 29, 2018 |
Recall Number | Z-2531-2017 |
Recall Event ID |
77406 |
510(K)Number | K131079 |
Product Classification |
Introducer, catheter - Product Code DYB
|
Product | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400 |
Code Information |
Lot # 363848 |
Recalling Firm/ Manufacturer |
Creganna Medical Devices Parkmore West Galway Ireland
|
Manufacturer Reason for Recall | Lack of sterility assurance. |
FDA Determined Cause 2 | Packaging |
Action | The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled. |
Quantity in Commerce | 100 uniits |
Distribution | Distributed in MA. |
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
|
|
|
|