Events

Recall of Device Recall Extremity Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Windstone Medical Packaging, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76280
  • Event Risk Class
    Class 2
  • Event Number
    Z-1295-2017
  • Event Initiated Date
    2017-01-11
  • Event Date Posted
    2017-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152837
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Light, surgical, ceiling mounted - Product Code FSY
  • Reason
    The medtronic cover light handle disposable gloves of the custom aligned medical solutions (ams) kits were recalled because gloves may contain splits or holes compromising sterility.
  • Action
    AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Device

Device Recall Extremity Pack
  • Model / Serial
    Lot number and expiration date  100226, 9/11/2019 101400, 10/7/2019 84373, 5/28/2018 84678, 6/8/2018 84896, 5/26/2018 84959, 7/29/2018 85470, 2/23/2017 85505, 7/23/2018 85547, 8/23/2018 85695, 7/8/2018 85846, 8/5/2018 86258, 9/19/2018 86509, 9/28/2018 86663, 8/11/2019 86686, 9/9/2018 86908, 9/13/2018 87155, 9/16/2018 87730, 7/5/2017 87968, 9/6/2018 88008, 7/1/2017 88862, 2/7/2018 89394, 11/15/2017 89546, 7/21/2017 89832, 12/29/2018 95313, 9/16/2019 95453, 1/22/2019 95880, 6/12/2019 96000, 1/6/2019 96383, 5/25/2018 96384, 5/13/2018 96923, 5/1/2019 97709, 5/1/2019 99376, 6/7/2019
  • Product Classification
    General and Plastic Surgery Devices
  • 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
    Extremity Pack, part number AMS3240 || Extremity Pack, part number AMS4764 || Extremity Pack, part number AMS4788(A || Extremity Pack, part number PSS1798(A || Extremity Pack, part number PSS1798(A || Extremity Pack, part number PSS1798(A || Extremity Pack, part number PSS1842(A || Extremity Pack, part number PSS1842(A || Extremity Pack, part number PSS1842(A || Extremity Pack, part number PSS1842(A || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part numbre PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706 || Extremity Pack, part number PSS2706(A || Extremity Pack, part number PSS2706(A || Extremity Pack, part number PSS2706(A || Extremity Pack, part number PSS2706(A
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

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