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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 Packsee related information
Date Initiated by FirmMarch 16, 2017
Date PostedApril 11, 2017
Recall Status1 Terminated 3 on June 06, 2017
Recall NumberZ-1798-2017
Recall Event ID 76774
Product Classification Light, surgical, ceiling mounted - Product Code FSY
ProductSetup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Code Information Lot numbers:   84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020
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		AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAMS sent an Urgent Medical Device Recall letter dated March 16, 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 should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com. Customers can call Aligned Medical Solutions at 321-527-7714.
Quantity in Commerce500 kits
DistributionNationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
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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