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U.S. Department of Health and Human Services

Class 2 Device Recall Virginia Custom Pack

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  Class 2 Device Recall Virginia Custom Pack see related information
Date Initiated by Firm April 22, 2015
Create Date October 20, 2016
Recall Status1 Terminated 3 on October 25, 2016
Recall Number Z-0284-2017
Recall Event ID 71968
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Virginia Custom Pack, Kit number RMS1744

convenience custom kits used for general surgery in hospital operating room
Code Information Lot Numbers/ Expiration Dates:  59798 9/26/2014 59796 7/5/2015 59797 7/5/2015 61329 7/5/2015 60411 8/5/2015 61222 9/1/2015 60758 9/9/2015 66544 11/5/2015 66261 11/7/2015 64654 11/8/2015 61679 11/9/2015 63209 11/13/2015 62471 11/17/2015 61678 11/27/2015 65932 11/30/2015 62470 12/9/2015 63208 12/18/2015 63927 1/5/2016 64653 1/7/2016 64307 1/18/2016 63926 1/20/2016 68195 7/5/2016 68638 7/7/2016 67670 7/16/2016 66545 7/23/2016 69868 9/15/2016 69907 9/17/2016 68874 9/25/2016 70705 10/25/2016 69039 10/27/2016 70945 12/5/2016 70704 1/4/2017 71513 1/27/2017 71688 3/6/2017 71840 3/6/2017 73729 4/17/2017 73177 4/20/2017 73393 4/21/2017 73731 5/16/2017 74648 5/30/2017 75024 7/3/2017 75160 7/11/2017 75975 7/21/2017 76242 8/3/2017 76441 8/18/2017 77269 8/22/2017 78308 9/26/2017 77268 10/8/2017 78593 11/4/2017 79038 11/20/2017 79881 1/7/2018 79039 2/28/2018  
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information Contact Vicki Davis
406-259-6387
Manufacturer Reason
for Recall		 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees. Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes. Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution. AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well. Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE Medtronic announced the recall l of Devon Light Glove contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. 1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside 2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875. For any questions about this recall, please call 321-527-7714. For questions regarding this recall call 404-259-6387.
Quantity in Commerce 5388 kits
Distribution Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
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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