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U.S. Department of Health and Human Services

Class 2 Device Recall Cataract Kit

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  Class 2 Device Recall Cataract Kit see related information
Date Initiated by Firm March 16, 2017
Date Posted April 11, 2017
Recall Status1 Terminated 3 on June 06, 2017
Recall Number Z-1783-2017
Recall Event ID 76774
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Cataract Kit, part numbers CAT1467AM and CAT1538(B.

Product packaged in a convenient manner for use in a general clinical procedure
Code Information Lot numbers: 76819 76820 78070 78533 78534 78535 79189 79972 80673 80674 80696 81600 82230 83093 83094 83585 83899 84580 85193 86565 86956 87679 88237 88915 88917 89946 95370 95574 95575 96215 96720 97384 97669 99621 99816 99881 101220 
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		 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
Action AMS 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 Commerce 4,065 kits
Distribution Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
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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