Recall Z-0377-2014 ยท HCH Clip, Aneurysm
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.
| Date | Nov 22, 2013 (initiated Oct 10, 2013) |
| Status | Terminated |
| 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 instruct |
| Quantity | 32 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990202 | SUGITA TITANIUM ANEURYSM CLIP Mizuho America, Inc., Jun 4, 1999 |