The FDA issued a safety alert on MedWatch advising counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects are being sold in the United States. This mesh is labeled with the C. R. Bard/Davol brand name. They are not Bard-manufactured products.

WARNING TO ALL HEALTHCARE SURGICAL FACILITIES

Healthcare professionals and facilities should carefully examine all manufacturers' polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the linked Initial Communication, and set out in the following chart.

Product

Lot

0112650 - Bard Flat Mesh 2" x 4"

Lot 48HVS036
Lot 43APD007

0112660 - Bard Flat Mesh 10" x 14"

Lot HUSD0629
Lot HURL0336

0112680 - Bard Flat Mesh 3" x 6"

Lot 43HPD027
Lot 43HPD032
Lot HUSG0540
Lot 43HDP027
Lot HUSE0532
Lot 43LPD507
Lot HUSF0763
Lot 43IOD011
Lot 43IPD038

0112720 - Bard Flat Mesh 6" x 6"

Lot 43FQD327

 

Contact Bard at 1-800-556-6275 if you think you have one of the counterfeit products.

If you believe you have received counterfeit or suspect product, contact FDA's Office of Criminal Investigations by calling 800-551-3989 or by visiting the Office of Criminal Investigations1 web site.

Steve Lombardi
Iowa personal injury, workers' compensation, motorcycle, quadriplegic, paraplegic, brain injury, death
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