Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral ane

FDA device recall Z-0377-2014 · posted 2013-11-22 · Terminated

Recall details

Recalling firm

Mizuho America, Inc.

Reason for recall

Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

Action taken

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

Status

Terminated

Product code

HCH

Quantity affected

32

Distribution

Nationwide Distribution

Date initiated

2013-10-10

Date posted

2013-11-22

Date terminated

2014-01-13

Location

Union City, CA

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