FDAFDA · Alimentos y medicamentos·N.º oficial Z-1475-2013
SlingBar Wide 670. Designed to meet the needs for lifting humans.
Publicado el 12 de junio de 2013 · Inicio del retiro: 30 de abril de 2013
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
Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hill-Rom, Inc.
- Distribuidor
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.
- Lote
- Product # 3156012, 3156017
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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