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U.S. Department of Health and Human Services

Class 2 Device Recall Breast Augmentation Pack

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  Class 2 Device Recall Breast Augmentation 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-1276-2017
Recall Event ID 76280
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Breast Augmentation Pack, part number AMS1786(A
Breast Augmentation Pack, part number AMS2790(A
Breast Augmentation Pack, part number AMS3324(B
Breast Augmentation Pack, part number AMS4382
Breast Augmentation Pack, part number AMS4382(A
Breast Augmentation Pack, part number AMS4382(B
Breast Augmentation Pack, part number AMS4392
Breast Augmentation Pack, part number PSS3430
Code Information Lot number and expiration date  100634, 9/23/2018 83241, 6/20/2017 83757, 6/1/2017 84174, 1/14/2017 84249, 1/20/2017 84496, 6/21/2017 84521, 3/19/2017 84904, 4/28/2017 84910, 1/25/2017 85071, 11/30/2017 85126, 6/28/2017 85126, 6/28/2017 85162, 1/17/2017 85565, 1/24/2017 85634, 6/11/2017 85820, 3/25/2017 85831, 6/14/2017 85985, 7/15/2017 86062, 4/21/2017 86141, 3/19/2017 86656, 7/10/2017 86797, 2/5/2018 86862, 6/18/2017 87093, 6/26/2017 87110, 8/22/2017 87747, 3/21/2017 88532, 2/11/2018 89014, 9/9/2017 89155, 12/22/2017 89244, 12/13/2017 89569, 12/3/2017 89770, 5/3/2017 89932, 7/7/2017 94601, 5/16/2017 95184, 7/29/2017 95185, 5/12/2017 95224, 5/1/2017 95265, 3/20/2018 95623, 9/22/2017 95793, 12/1/2017 96299, 5/22/2019 96563, 3/28/2018 96987, 5/21/2017 97563, 12/22/2017 97564, 3/30/2018 97902, 2/9/2018 98436, 3/7/2018 98445, 12/25/2018 98900, 2/28/2018 98937, 9/12/2018 98980, 2/3/2018 99258, 3/8/2018
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 1436 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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