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U.S. Department of Health and Human Services

Class 2 Device Recall SetUp Pack

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  Class 2 Device Recall SetUp 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-1367-2017
Recall Event ID 76280
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Set-Up Pack, part number PSS1305(C
Code Information Lot number and expiration date  100280, 9/22/2019 101104, 9/14/2019 84089, 6/29/2018 85293, 7/29/2018 85807, 8/21/2018 86209, 9/23/2018 86427, 8/9/2018 86627, 8/11/2019 87734, 9/29/2018 87934, 9/7/2018 87935, 11/21/2018 87936, 12/25/2018 87937, 12/29/2018 89476, 1/28/2019 95646, 1/10/2019 96062, 1/16/2019 96463, 3/8/2019 96464, 6/22/2019 96465, 5/28/2019 96466, 5/29/2019 96807, 6/6/2019 97610, 6/19/2019 97611, 6/17/2019 97878, 9/25/2019 97878, 9/25/2019 99195, 9/14/2019 
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 1275 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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