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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Breast Augmentation Pack

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 Class 2 Device Recall Custom Breast Augmentation Packsee related information
Date Initiated by FirmJanuary 11, 2017
Date PostedFebruary 28, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-1283-2017
Recall Event ID 76280
Product Classification Light, surgical, ceiling mounted - Product Code FSY
ProductCustom Breast Augmentation Pack, part number PSS2455(D
Code Information Lot number and expiration date  100294, 5/29/2018 84142, 5/25/2017 85025, 5/25/2017 88222, 5/25/2017 88310, 5/25/2017 89226, 5/25/2017 96139, 7/6/2017 96969, 7/30/2017 97625, 7/27/2017 
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information ContactVicki 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
ActionAMS 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 Commerce229 kits
DistributionDistributed 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 CycleTPLC 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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