Device Recall Laparotomy Pack

  • Model / Serial
    Lot number and expiration date  100128, 9/28/2019 84856, 1/31/2019 86767, 12/22/2018 87491, 10/22/2017 88562, 10/20/2017 89958, 12/15/2018 94988, 12/5/2017 95849, 12/3/2017 96246, 3/3/2019 97441, 6/4/2019 97888, 6/16/2018 98626, 6/24/2019 98972, 7/22/2018 99473, 6/6/2019
  • 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
    Laparotomy Pack, part number 006268-9 || Laparotomy Pack, part number AMS4418(A || Laparotomy Pack, part number PSS2190(A
  • Manufacturer
  • 1 Event

Manufacturer

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

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Code:900176 Lots: 141216310 exp. 12/31/15 150116977 exp. 1/31/16 150116977 exp. 1/31/16 150116775 exp. 1/31/16 150116772 exp. 1/31/16 150116774 exp. 1/31/16 150116773 exp. 1/31/16 150317694 exp. 3/31/16 150317695 exp. 3/31/16 150317696 exp. 3/31/16 150317697 exp. 3/31/16 150317698 exp. 3/31/16 150317693 exp. 3/31/16 150418316 exp. 4/30/16 150418317 exp. 4/30/16 150418578 exp. 4/30/16 150418579 exp. 4/30/16 150519009 exp. 5/31/16 150619364 exp. 6/30/16 150619365 exp. 6/30/16 150619366 exp. 6/30/16 150619367 exp. 6/30/16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    LAPAROTOMY PACK CUSTOMED 7/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • Model / Serial
    Code:9002516 Lots: 140915508 exp. 11/30/15 140915508 exp. 11/30/15 141216306 exp. 12/31/15 150116544 exp. 1/31/16 150116544 exp. 1/31/16 150418376 exp. 4/30/16 150317845 exp. 4/30/16 150418377 exp. 5/31/16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    LAPAROTOMY PACK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • Model / Serial
    Code:900848 Lots: 140915201 exp. 1/31/16 140915249 exp. 11/30/15 150318126 exp. 4/30/16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    LAPAROTOMY PACK CS/6 || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • Model / Serial
    Code: 900996 Lots: 141015747 exp. 11/30/15 150116833 exp. 2/28/16 150317665 exp. 3/31/16 150318129 exp. 3/31/16 150518851 exp. 5/31/16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    LAPAROTOMY PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
  • Manufacturer
  • Model / Serial
    Lot: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to Louisiana and Montana.
  • Product Description
    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. || There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.
  • Manufacturer
One more