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U.S. Department of Health and Human Services

Class 2 Device Recall General Pack

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  Class 2 Device Recall General 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-1305-2017
Recall Event ID 76280
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product General Pack, part number AMS2967(A
General Pack, part number AMS3239(A
General Pack, part number AMS3709(B
General Pack, part number AMS5341
General Pack, part number AMS5694
Code Information Lot number and expiration date  100415, 9/23/2019 100737, 9/30/2019 100981, 10/20/2019 101069, 9/6/2019 101739, 10/19/2019 101816, 10/14/2019 83797, 5/12/2018 84203, 5/26/2018 84668, 5/17/2018 84793, 2/3/2019 85141, 6/8/2018 85421, 7/28/2018 85504, 8/30/2018 86008, 7/8/2018 86260, 9/9/2018 86481, 9/5/2018 86586, 9/27/2018 86774, 8/8/2018 86837, 9/12/2018 87291, 9/30/2018 87456, 9/30/2018 87754, 1/7/2019 88321, 9/6/2018 88648, 12/29/2018 88657, 12/2/2018 88764, 10/8/2018 89333, 12/25/2018 89429, 12/29/2018 94713, 12/14/2018 94739, 1/25/2019 94783, 12/16/2018 95286, 11/12/2018 95349, 1/10/2019 95432, 1/24/2019 95459, 1/21/2019 95928, 1/23/2019 95999, 3/9/2019 96009, 1/7/2019 96501, 1/6/2019 96934, 5/30/2019 97201, 5/5/2019 97338, 5/13/2019 97459, 6/4/2019 97854, 6/14/2019 98176, 6/29/2019 98263, 6/11/2019 98677, 6/3/2019 99291, 6/12/2019 99385, 6/11/2019 99682, 6/29/2019 99712, 6/5/2019 99889, 9/4/2019 99926, 9/27/2019  
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 1501 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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