Device Recall Mentor Aseptic Transfer Set

  • Model / Serial
    Aseptic Transfer Sets: All lots.  Syringes: Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. Product also sent to the following countries: Australia, Canada, Costa Rica, Korea, New Zealand and South Africa.
  • Product Description
    Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mentor Texas, Inc, 3041 Skyway Cir N, Irving TX 75038-3500
  • Source
    USFDA