Covidien LLC - Parietex Composite Parastomal Mesh - Class 2 Recall

Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts