Reported Aug 14, 2013 · Terminated
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and…
Cordis Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***
- Product UsageThe OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement
- in the vena cava in several situationsPulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated
- Lot codes and dates
- Model Numbers 466F220A and 466F220B.
- Amount recalled
- 33,000 units
Where it was sold
Why it was recalled
Stop using this product now
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Using this product could cause serious injury, illness or death — stop using it now.
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