FDAFDA · Alimentos y medicamentos·N.º oficial Z-2146-2017
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Publicado el 31 de mayo de 2017 · Inicio del retiro: 21 de abril de 2017
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
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardinal Health 200, LLC
- Distribuidor
- Nationwide Distribution
- Lote
- Catalog Number: SU130-1321 Lot Numbers: 1161206 1161207 1161370 1161371 1161372 1161476 1161477 1161478 1161606 1161607 1161608 1170036
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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