Device Recall Anorectal Manometry Probe

  • Modelo / Serial
    Product model # A86-5050. All lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.
  • Descripción del producto
    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Sandhill Scientific, Inc, 9150 Commerce Center Cir Ste 500, Highlands Ranch CO 80129-1563
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product model # A86-4050. All lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.
  • Descripción del producto
    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'
  • Manufacturer