Z-0377-2014 Class II Terminated
FDA device recall Z-0377-2014 was initiated by Mizuho America, Inc. on October 10, 2013 and is designated Class II. Reason for recall: Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored. The recall status is terminated (terminated January 13, 2014). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- October 10, 2013
- Termination Date
- January 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
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.
Distribution Pattern
Nationwide Distribution
Code Information
Product Code 17-001-56; Lot No. 27JY