FDAFDA · Alimentos y medicamentos·N.º oficial Z-1196-2014
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Publicado el 19 de marzo de 2014 · Inicio del retiro: 19 de febrero 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
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Gyrus Medical, Inc
- Distribuidor
- US Distribution.
- Lote
- Lots: MK761655, MK764022, MK767655, MK526401
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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