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U.S. Department of Health and Human Services

Class 2 Device Recall Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath

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  Class 2 Device Recall Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath see related information
Date Initiated by Firm May 22, 2017
Create Date June 14, 2017
Recall Status1 Terminated 3 on May 29, 2018
Recall Number Z-2529-2017
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 M004USTMCA85200
Code Information Lot # 364951, 385149
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 85 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 and Original Applicant = CREGANNA MEDICAL DEVICES
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