FDAFDA · Food and drugs·Recall number Z-0819-2014
Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Published January 29, 2014 · Recall initiated: January 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product labeling does not match product configuration.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Distributor
- Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
- Lot
- Lot# HUXH0294
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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