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U.S. Department of Health and Human Services

Class 2 Device Recall Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58

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  Class 2 Device Recall Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 see related information
Date Initiated by Firm October 10, 2013
Date Posted November 22, 2013
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-0378-2014
Recall Event ID 66561
510(K)Number K990202  
Product Classification Clip, aneurysm - Product Code HCH
Product Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58

Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
Code Information Product Code 17-001-58; Lot No. 29JY
Recalling Firm/
Manufacturer		 Mizuho America, Inc.
30057 Ahern Ave
Union City CA 94587-1234
For Additional Information Contact Karishma Vora Gariepy
510-324-4500 Ext. 122
Manufacturer Reason
for Recall		 Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
FDA Determined
Cause 2		 Process control
Action Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice. For questions regarding this recall call 510-324-4500, ext 122.
Quantity in Commerce 35
Distribution Nationwide Distribution
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 = HCH and Original Applicant = MIZUHO AMERICA, INC.
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