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U.S. Department of Health and Human Services

Class 2 Device Recall Extremity Pack

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  Class 2 Device Recall Extremity 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-0183-2017
Recall Event ID 71968
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A
PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706

convenience custom kits used for general surgery in hospital operating room
Code Information Lot Numbers/Expiration Dates:  59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015 61013 9/14/2015 64817 10/10/2015 61618 10/15/2015 61383 10/18/2015 64593 10/19/2015 64969 11/3/2015 65776 11/5/2015 64394 11/14/2015 63778 11/15/2015 65580 11/16/2015 61938 11/17/2015 62567 11/18/2015 61626 11/20/2015 66917 11/21/2015 61343 11/22/2015 66393 11/23/2015 62154 11/23/2015 66584 11/26/2015 63230 12/18/2015 66183 12/24/2015 64380 1/4/2016 63989 1/7/2016 63404 1/9/2016 78771 1/9/2016 63992 1/11/2016 64696 1/13/2016 64395 1/14/2016 63779 1/18/2016 73914 3/2/2016 73298 3/16/2016 73714 3/23/2016 56866 5/22/2016 57094 5/23/2016 57068 5/24/2016 77013 6/4/2016 70913 6/6/2016 74518 6/8/2016 57067 6/10/2016 71703 6/14/2016 57216 6/19/2016 76121 6/21/2016 57511 6/22/2016 67763 7/1/2016 69284 7/16/2016 70977 7/17/2016 72321 7/17/2016 58092 7/20/2016 67097 7/23/2016 58319 7/25/2016 77988 7/30/2016 77053 7/30/2016 78132 7/30/2016 77721 7/30/2016 58935 8/21/2016 59057 8/22/2016 57588 8/23/2016 72894 8/25/2016 68286 8/25/2016 59210 8/28/2016 70323 9/11/2016 68755 9/22/2016 69925 9/22/2016 70567 9/24/2016 68888 9/26/2016 70568 9/28/2016 77749 10/21/2016 70298 10/23/2016 69708 10/24/2016 71084 10/28/2016 69471 10/31/2016 69083 11/24/2016 71424 12/11/2016 72789 1/10/2017 72318 1/10/2017 70981 1/21/2017 72960 1/21/2017 73548 1/22/2017 73097 3/13/2017 73917 4/18/2017 74272 4/24/2017 74822 5/14/2017 75045 5/24/2017 74474 5/25/2017 75351 6/20/2017 77597 7/19/2017 75822 7/23/2017 76486 7/27/2017 74084 8/4/2017 76956 8/7/2017 79077 9/10/2017 78131 9/19/2017 77601 10/9/2017 77531 10/10/2017 78761 11/5/2017 78757 11/9/2017 79263 11/23/2017 78470 1/5/2018 79339 1/16/2018 80751 1/23/2018 79337 1/25/2018 79604 2/25/2018 80517 2/25/2018 
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 3829 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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