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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheathsee related information
Date Initiated by FirmMay 22, 2017
Create DateJune 14, 2017
Recall Status1 Terminated 3 on May 29, 2018
Recall NumberZ-2531-2017
Recall Event ID 77406
510(K)NumberK131079 
Product Classification Introducer, catheter - Product Code DYB
ProductBoston 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
ActionThe firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.
Quantity in Commerce100 uniits
DistributionDistributed in MA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DYB
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