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Class 2 Device Recall Shoulder 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-1368-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B
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Code Information |
Lot number and expiration date 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21/2018 85549, 7/13/2018 85838, 8/1/2018 86718, 9/5/2018 87103, 9/12/2018 87106, 9/15/2018 87277, 8/10/2019 87347, 6/22/2018 87916, 6/22/2019 87962, 11/15/2018 88047, 9/4/2018 88376, 12/29/2018 89418, 11/12/2018 94736, 1/21/2019 95273, 6/12/2019 96914, 6/15/2019 97450, 5/11/2019 98491, 9/27/2019 98503, 6/6/2019 99369, 9/27/2019 |
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 |
606 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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