FDAFDA · Alimentos y medicamentos·N.º oficial Z-1839-2015
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.
Publicado el 1 de julio de 2015 · Inicio del retiro: 8 de mayo de 2015
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
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ethicon, Inc.
- Distribuidor
- Worldwide Distribution -- US (nationwide) and Canada.
- Lote
- Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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