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Class 2 Device Recall Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath |
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Date Initiated by Firm |
May 22, 2017 |
Create Date |
June 14, 2017 |
Recall Status1 |
Terminated 3 on May 29, 2018 |
Recall Number |
Z-2530-2017 |
Recall Event ID |
77406 |
510(K)Number |
K131079
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Product Classification |
Introducer, catheter - Product Code DYB
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Product |
Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100 |
Code Information |
Lot # 383271, 384264 |
Recalling Firm/ Manufacturer |
Creganna Medical Devices Parkmore West Galway Ireland
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Manufacturer Reason for Recall |
Lack of sterility assurance.
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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 |
150 units |
Distribution |
Distributed in MA. |
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 and Original Applicant = CREGANNA MEDICAL DEVICES
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