Devices

Device Recall Custom Procedural Trays

  • Model / Serial
    Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: US including states of: NE and SD.
  • Product Description
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
  • Manufacturer
    Merit Medical Systems, Inc.
  • 1 Event

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 12701 N Kingston Ave, Chester VA 23836-2700
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Custom Procedural Trays
  • Model / Serial
    Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Military Hospital on base in Landstuhl, Germany
  • Product Description
    Custom Procedural Trays: Merit's Custom Angio Kits || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
  • Manufacturer
    Merit Medical Systems, Inc.