Device Recall Custom Pack with Introducer Kit

  • Model / Serial
    Lot number and expiration date  85014, 4/30/2018 85448, 7/14/2018 85937, 8/23/2018 87713, 8/9/2018 88092, 11/18/2018 89342, 10/17/2018 89974, 12/5/2018 95212, 12/3/2018 95725, 12/19/2018 96882, 12/9/2018 97051, 5/27/2019 98088, 5/2/2019 98423, 5/25/2019 98852, 5/14/2019
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
  • Product Description
    Custom Pack - with Introducer Kit, part number TVS4011NI(L
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
  • Manufacturer Parent Company (2017)
  • Source
    USFDA