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Class 2 Device Recall Knee 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-1320-2017 |
Recall Event ID |
76280 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
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Code Information |
Lot number and expiration date 100023, 9/22/2019 100595, 9/1/2019 84529, 5/13/2018 84584, 5/26/2018 84728, 5/25/2018 85250, 7/22/2018 85273, 7/10/2018 85645, 8/1/2018 85845, 8/19/2018 87286, 8/11/2019 87350, 9/21/2018 87967, 9/24/2018 88173, 11/11/2018 88390, 11/21/2018 88627, 12/24/2018 89082, 10/3/2018 89422, 12/16/2018 89511, 11/13/2018 94573, 11/19/2018 94941, 11/20/2018 95452, 5/6/2019 95985, 3/8/2019 97273, 5/22/2019 98169, 6/26/2019 98664, 6/25/2019 98675, 6/23/2019 99375, 6/12/2019 |
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 |
700 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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