Recall Z-0378-2014— 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 Mini Type No 58 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 Mini Type No 58 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.