FLEXI NOZZLE LONG

  • Model / Serial
    Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
  • Product Description
    FLEXI NOZZLE LONG, 10 Boxes of 25 units each || Product Usage: || These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
  • Source
    USFDA