FDAFDA · Alimentos y medicamentos·N.º oficial Z-1855-2012
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Publicado el 27 de junio de 2012 · Inicio del retiro: 13 de junio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Sterility of product may be compromised due to packaging defect
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Genzyme Corporation
- Distribuidor
- Worldwide Distribution - US (nationwide) and the country of S. Korea
- Lote
- Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States