Recall Z-0377-2014— Mizuho America, Inc.
Class II · Terminated
Class II FDA medical device recall by Mizuho America, Inc., initiated 2013-10-10, terminated 2014-01-13. It names one FDA 510(k) clearance: K990202. 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.. Reason: Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored..
- Recalling firm
- Mizuho America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-10
- Terminated
- 2014-01-13
- Firm location
- Union City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
Data sourced from openFDA. This site is unofficial and independent of the FDA.