FDAFDA · Alimentos y medicamentos·N.º oficial Z-2416-2012
Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Publicado el 26 de septiembre de 2012 · Inicio del retiro: 22 de junio de 2010
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
The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Kimberly-Clark Corporation
- Distribuidor
- Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
- Lote
- Lots AW916002A, AW916102D
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States