Zilver 518 Vascular Self Expanding Stent The Zilver recall
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in…
Why was Zilver 518 Vascular Self Expanding Stent The Zilver recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
- Product
- Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in…
- Recalling firm
- Cook Ireland Ltd.
- Quantity
- 15 units of ZIV5-18-125-8-80 LOT# CF694429
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Japan.
- Recall date
- September 12, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)