BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
Publicado el 6 de marzo de 2013 · Inicio del retiro: 4 de octubre 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
A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baylis Medical Company Inc.
- Distribuidor
- International distribution to the country of Australia.
- Lote
- Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Canada
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