Reported May 22, 2013 · Terminated
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and…
Integra LifeSciences Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corporation · 105 Morgan Ln · Plainsboro, NJ · 08536-3339
Is this the product you have?
- DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
- Lot codes and dates
11255231125517 11255221125539 11255241125525 11255261125632 11256301125678 1125679 11256771125683 11256281125813 11258141125815 11256291125520 11255211125979 11260311125980 11259811125982 11260301130243 11300711130503 11303791130381 11303841130507 11303741130380 11303821130421 11305051130424 11306541130422 11304231130428 11306391130413 11304141130383 11304251130504 11305061130426 11304271130970 11308271111606 11048791110814 11116101104876 11108151111607 11102681111360 11123391104405 11048771105455 11120081112110 11121111110845 11119401112149 11048801112148 11102441110265 11108461104878 11116091111941 1104881111081211102671111359111234011053071111611111193911123411110266 11121461112147
- Amount recalled
- 21,179 boxes
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
This product could cause temporary or reversible health problems — stop using it.
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