Composix L/P with Echo PS 6" X 8" Product Code 0144680 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.
Recall
- Recall Number
- Z-0820-2014
- Event Number
- 67149
- Firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- FEI Number
- 1213643
- Product Code
- FTL
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- January 3, 2014
- Posted
- January 23, 2014
- Terminated
- December 23, 2015
- Address
- 100 Crossings Blvd, Warwick, RI, 02886-2850
Description
Composix L/P with Echo PS 6" X 8" Product Code 0144680 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.
Product labeling does not match product configuration.
Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,
Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
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