Class 2 Device Recall Custom Pack

• Date Initiated by Firm: January 11, 2017
• Date Posted: February 28, 2017
• Recall Status: Terminated on May 03, 2017
• Recall Number: Z-1284-2017
• Recall Event ID: 76280
• Product Classification: Light, surgical, ceiling mounted - Product Code FSY
• Product: Custom Pack, part number AMS4776; Custom Pack, part number AMS4776(A; Custom Pack, part number AMS5643; Custom Pack, part number AMS5643(A; Custom Pack, part number AMS6012; Custom Pack, part number AMS6383; Custom Pack, part number PSS2135(B; Custom Pack, part number PSS2798(B; Custom Pack, part number PSS2798(C; Custom Pack, part number PSS3463
• Code Information: Lot number and expiration date 100084, 10/2/2019 100678, 10/22/2019 100683, 10/13/2019 100700, 9/5/2019 100771, 7/9/2019 100772, 7/23/2019 101188, 9/6/2019 101555, 9/9/2019 84253, 5/12/2018 84254, 5/25/2018 84377, 9/10/2018 84493, 5/28/2018 84494, 5/28/2018 84495, 6/22/2018 84681, 7/22/2018 84682, 7/29/2018 84853, 7/22/2018 84919, 6/3/2018 86006, 8/22/2018 86135, 9/29/2018 86853, 10/31/2018 87162, 8/10/2019 87171, 8/20/2018 87229, 10/5/2018 87582, 12/28/2018 87615, 12/17/2018 88006, 9/23/2018 88227, 9/5/2018 88559, 11/14/2018 88573, 11/12/2018 88574, 11/14/2018 88692, 2/28/2018 88693, 12/9/2018 88899, 11/24/2018 89221, 12/7/2018 89554, 12/9/2018 89555, 1/6/2019 89762, 1/10/2019 94731, 11/12/2018 95058, 1/18/2019 95061, 1/13/2019 95477, 12/7/2018 95510, 1/25/2019 95631, 3/7/2019 95654, 1/10/2019 95874, 6/27/2019 96054, 1/13/2019 96361, 3/10/2019 96458, 1/25/2019 96477, 1/25/2019 96478, 6/23/2019 96834, 6/10/2019 96988,6/9/2019 97000, 6/29/2019 97166, 5/11/2019 97547, 5/7/2019 97820, 6/7/2019 98230, 6/8/2019 98588, 6/7/2019 98753, 6/3/2019 99515, 9/21/2019 99516, 9/30/2019 99564, 9/8/2019 99603, 10/4/2019
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: Vicki Davis; 321-527-7714
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 4155 kits
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.