Device Recall Percutaneous Entry Kit

  • Model / Serial
    Lot number and expiration date  80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 6/12/2019
  • 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
    Percutaneous Entry Kit, part number TVS4022(D || Percutaneous Entry Kit , part number TVS4022(E || Percutaneous Entry Kit, part number TVS4022(F
  • Manufacturer
  • 1 Event

Manufacturer

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