Device Recall FlexTray Procedure Delivery System

  • Model / Serial
    Lot Numbers: E4MR6R, E4ML22, E4MG62, E4MJ7M, and E4MN2V.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
  • Source
    USFDA