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U.S. Department of Health and Human Services

Class 2 Device Recall Basic Pack

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  Class 2 Device Recall Basic Pack see related information
Date Initiated by Firm January 11, 2017
Date Posted February 28, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1267-2017
Recall Event ID 76280
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Basic Pack, part number AMS1868(B
Basic Pack, part number AMS2608(A
Basic Pack, part number AMS3861
Basic Pack, part number AMS4309
Basic Pack, part number PSS1833
Basic Pack, part number PSS1833(A
Basic Pack, part number PSS1848(A
Code Information Lot number and expiration date  100394, 9/15/2019 100593, 9/21/2019 100594, 10/5/2019 101063, 10/15/2019 101304, 10/23/2019 83725, 6/8/2018 84749, 9/11/2018 85159, 8/1/2018 85635, 8/6/2018 85810, 7/19/2018 86252, 9/2/2018 86440, 8/7/2018 86859, 8/18/2018 86939, 11/22/2018 87105, 9/15/2018 87269, 9/30/2018 87351, 9/15/2018 87447, 11/11/2018 87942, 9/23/2018 88172, 12/3/2018 88282, 9/7/2018 88368, 9/5/2018 88846, 12/11/2018 88887, 12/7/2018 89004, 10/8/2018 89160, 12/1/2018 89438, 11/22/2018 89512, 10/9/2018 89716, 1/9/2019 89743, 12/3/2018 89811, 12/1/2018 94572, 12/15/2018 94705, 12/15/2018 94751, 1/4/2019 94853, 1/27/2019 94935, 1/25/2019 95293, 1/26/2019 95412, 1/25/2019 95936, 1/11/2019 95974, 5/29/2019 96023, 1/16/2019 96255, 1/2/2019 96410, 3/7/2019 96566, 3/9/2019 96678, 5/24/2019 96913, 5/22/2019 97124, 5/12/2019 97410, 6/3/2019 97577, 5/1/2019 97780, 6/15/2019 98017, 6/29/2019 98312, 6/24/2019 98478, 6/29/2019 98502, 6/6/2019 98663, 6/28/2019 98633, 6/30/2019 99172, 6/12/2019 99581, 6/27/2019 99703, 9/27/2019 99843, 9/30/2019 99887, 9/11/2019 99913, 9/23/2019 
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 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 2388 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.
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