3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.
Publicado el 25 de septiembre de 2013 · Inicio del retiro: 5 de agosto 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
3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no repo
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- 3M Company - Health Care Business
- Distribuidor
- Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA..
- Lote
- Catalog # - Lot # WDP2 - 792920, 793090, 793640 & 796078. WDP3 - 792921, 793098, 793638, 796077 & 798487. WDP4 - 792922, 793116, 793637, 796079 & 798488. WDP6 792923, 793636, 798489, 799235 & 799236
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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