Mizuho America, Inc.: Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

Recall number

Z-0377-2014

Recalling firm

Mizuho America, Inc.

Product

Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

Status

Terminated

Initiated

2013-10-10

Posted

2013-11-22

Terminated

2014-01-13

Reason

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

Root cause

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

32

Distribution

Nationwide Distribution

Lot, serial or model codes

Product Code 17-001-56; Lot No. 27JY

510(k) numbers

["K990202"]

PMA numbers

not on file

Product code

HCH

Firm FEI

1000159388

Firm city

Union City

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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