Cordis OPTEASE Retrieval Inferior Vena Cava recall: Labeling Error
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP…
Why was Cordis OPTEASE Retrieval Inferior Vena Cava recalled?
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
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?
Model Numbers 466F220A and 466F220B.
- Product
- Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP…
- Recalling firm
- Cordis Corporation
- Quantity
- 33,000 units
- Distribution
- Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, Ny, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama
- Recall date
- August 14, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)