TransCyte
ORGANOGENESIS INC. · Model 10633 · UDI-DI 00618474000046
Description
TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-02-21 | Organogenesis, Inc. | Product sterility may be compromised |
| 2011-01-30 | Organogenesis, Inc. | Product sterility compromised |
| 2010-08-02 | Organogenesis, Inc. | Product is contaminated with a yeast identified as Pseudozyma antarctica. |
| 2009-09-27 | Organogenesis, Inc. | Unit contaminated with Staphylococcus epidermidis |
| 2007-12-26 | Organogenesis, Inc. | Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative r |
| 2006-09-29 | Organogenesis, Inc. | Product pH out of specification |
| 2003-05-02 | Smith and Nephew Wound Management (La Jolla) | Did not meet finished device specifications for the DNA criteria. |
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