Device Recall Breast Augmentation Pack

  • Model / Serial
    Lot number and expiration date  100634, 9/23/2018 83241, 6/20/2017 83757, 6/1/2017 84174, 1/14/2017 84249, 1/20/2017 84496, 6/21/2017 84521, 3/19/2017 84904, 4/28/2017 84910, 1/25/2017 85071, 11/30/2017 85126, 6/28/2017 85126, 6/28/2017 85162, 1/17/2017 85565, 1/24/2017 85634, 6/11/2017 85820, 3/25/2017 85831, 6/14/2017 85985, 7/15/2017 86062, 4/21/2017 86141, 3/19/2017 86656, 7/10/2017 86797, 2/5/2018 86862, 6/18/2017 87093, 6/26/2017 87110, 8/22/2017 87747, 3/21/2017 88532, 2/11/2018 89014, 9/9/2017 89155, 12/22/2017 89244, 12/13/2017 89569, 12/3/2017 89770, 5/3/2017 89932, 7/7/2017 94601, 5/16/2017 95184, 7/29/2017 95185, 5/12/2017 95224, 5/1/2017 95265, 3/20/2018 95623, 9/22/2017 95793, 12/1/2017 96299, 5/22/2019 96563, 3/28/2018 96987, 5/21/2017 97563, 12/22/2017 97564, 3/30/2018 97902, 2/9/2018 98436, 3/7/2018 98445, 12/25/2018 98900, 2/28/2018 98937, 9/12/2018 98980, 2/3/2018 99258, 3/8/2018
  • 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
    Breast Augmentation Pack, part number AMS1786(A || Breast Augmentation Pack, part number AMS2790(A || Breast Augmentation Pack, part number AMS3324(B || Breast Augmentation Pack, part number AMS4382 || Breast Augmentation Pack, part number AMS4382(A || Breast Augmentation Pack, part number AMS4382(B || Breast Augmentation Pack, part number AMS4392 || Breast Augmentation Pack, part number PSS3430
  • Manufacturer
  • 1 Event

Manufacturer

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