notyard
04-14-2009, 12:59 PM
FDA class III recall:
PRODUCT
Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531. Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product. Recall # Z-0935-2009
CODE
Lot number: 43JQD016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated December 25, 2008.
Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall is ongoing.
REASON
Mislabeled; Product labeled as left large, may contain a Right Large.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
Nationwide
PRODUCT
Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531. Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product. Recall # Z-0935-2009
CODE
Lot number: 43JQD016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated December 25, 2008.
Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall is ongoing.
REASON
Mislabeled; Product labeled as left large, may contain a Right Large.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
Nationwide