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Class 2 Device Recall Upper Extremity 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-1378-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
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Code Information |
Lot number and expiration date 100052, 9/16/2018 84369, 6/20/2017 84721, 6/26/2017 84951, 6/21/2017 85377, 7/26/2017 86594, 10/8/2017 86595, 10/11/2017 87312, 10/24/2017 87990, 10/6/2017 88277, 10/26/2017 88668, 11/1/2017 89203, 12/16/2017 89605, 12/17/2017 94907, 12/28/2017 94968, 12/5/2017 95303, 2/27/2018 95476, 2/20/2018 96326, 2/1/2018 96619, 2/10/2018 96788, 2/1/2018 96950, 1/5/2018 97302, 3/20/2018 97596, 4/28/2018 97819, 3/15/2018 98048, 3/24/2018 98529, 5/30/2018 98710, 6/10/2018 98945, 5/24/2018 98946, 6/7/2018 |
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 |
1787 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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