Device Recall FlexTray Procedure Delivery System

  • Modèle / numéro de série
    Lot Numbers: E4MR6R, E4ML22, E4MG62, E4MJ7M, and E4MN2V.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico.
  • Description du dispositif
    FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. || Intended for transection, resection, and/or creation of anastomoses.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
  • Source
    USFDA