FDAFDA · Alimentos y medicamentos·N.º oficial Z-1296-2014
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Publicado el 2 de abril de 2014 · Inicio del retiro: 11 de marzo de 2014
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
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Teleflex Medical
- Distribuidor
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Lote
- Product Code: X-6371M5, Lot numbers: 02E0801603
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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