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Class 2 Device Recall Arthroscopy Pack |
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Date Initiated by Firm |
January 11, 2017 |
Date Posted |
February 28, 2017 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number |
Z-1261-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
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Code Information |
Lot Numbers and Expiration Dates 83622, 5/19/2018 84374, 5/24/2018 84729, 5/17/2017 84897, 5/26/2018 84946, 6/24/2017 85171, 6/9/2018 85363, 7/20/2017 85548, 7/15/2018 85696, 8/22/2018 85698, 7/21/2017 86510, 9/29/2018 86687, 9/5/2018 86889, 7/11/2017 86909, 9/12/2018 87156, 8/1/2018 87157, 9/5/2018 87159, 10/23/2017 87289, 10/17/2017 87978, 10/31/2017 88401, 10/7/2017 88549, 10/28/2017 88656, 12/7/2017 89219, 12/22/2017 89904, 1/23/2017 94742, 12/29/2017 95143, 12/4/2017 95284, 2/2/2018 95315, 2/20/2018 95840, 2/13/2018 96006, 1/7/2018 96469, 2/27/2018 96631, 1/8/2018 96821, 3/25/2018 96931, 2/1/2018 97751, 3/2/2018 98923, 3/20/2018 98971, 9/19/2018 |
Recalling Firm/ Manufacturer |
Windstone Medical Packaging, Inc. 1602 4th Ave N Billings MT 59101-1521
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For Additional Information Contact |
Vicki Davis 321-527-7714
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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.
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FDA Determined Cause 2 |
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 |
1,081 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
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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.
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