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.
FDA Recall Z-0378-2014 · Posted 2013-11-22
Recalling FirmMizuho America, Inc.
Recall StatusTerminated
Product CodeHCH
Date Initiated2013-10-10
Date Terminated2014-01-13
Product Quantity35
Reason for Recall
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.