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 Status: Terminated on May 29, 2018
• Recall Number: Z-2530-2017
• Recall Event ID: 77406
• 510(K)Number: K131079
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
• Code Information: Lot # 383271, 384264
• FEI Number: 3004193842
• Recalling Firm/ Manufacturer: Creganna Medical Devices; Parkmore West; Galway Ireland
• Manufacturer Reason for Recall: Lack of sterility assurance.
• FDA Determined Cause: 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

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