Enforcement Report - Week of September 12, 2012
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Product Detail
| Product Description | Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment. |
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| Recall Number | Z-2309-2012 |
| Classification | Class II |
| Code Info | Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014 |
| Product Distributed Qty | 15 units of ZIV5-18-125-8-80 LOT# CF694429 |
| Reason For Recall | Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35-80-10-30) rather than a 5 French size. |
Event Detail
| Event Id | 61451 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Cook Ireland Ltd. |
| City | Limerick, Peroc |
| State | Country | IE |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-01-05 |
| Initial Firm Notification of Consignee or Public | Other |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and country of: Japan. |
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