• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Recall Number Z-0505-2014
Classification Class II
Code Info 17011012
Product Distributed Qty
Reason For Recall Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

Event Detail

Event Id 66888
Product Type Devices
Status Ongoing
Recalling Firm Stryker Neurovascular
City Fremont
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan
-
-