The Recall Desk

FDA (Devices) recall action 66561

Mizuho America, Inc. recalled 2 products on 2013-12-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-12-04
Critical
0
Units
67

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 35 units of Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58 due to discoloration in specific lots.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 32 units of Sugita Titanium Standard Aneurysm Clip II due to discoloration. The devices are intended for single use in cerebral aneurysms.

    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.
    Category
    Distribution
    0 states