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U.S. Department of Health and Human Services

Class 2 Device Recall Arthroscopy Pack

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 Class 2 Device Recall Arthroscopy Packsee related information
Date Initiated by FirmApril 22, 2015
Create DateOctober 20, 2016
Recall Status1 Terminated 3 on October 25, 2016
Recall NumberZ-0142-2017
Recall Event ID 71968
Product Classification Light, surgical, ceiling mounted - Product Code FSY
ProductArthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
Code Information Lot Numbers/ Expiration Dates:  66444 2/5/2015  73046 1/1/2016 74702 3/18/2016 73595 4/17/2016 78038 7/30/2016 76691 9/1/2016 78555 9/11/2016 78554 10/19/2016  56085 6/6/2016 59697 8/1/2015 67248 7/16/2016 68753 9/12/2016 69101 9/3/2016 78129 8/23/2017 80761 2/1/2018  60666 10/19/2014 59667 7/19/2015 60265 7/19/2015 60266 7/22/2015 60267 7/24/2015 61386 8/20/2015 60268 8/25/2015 60269 8/26/2015 61384 9/17/2015 61385 9/27/2015 61388 10/13/2015 61389 10/15/2015 65208 10/19/2015 61387 11/7/2015 63013 11/14/2015 65740 11/15/2015 65803 11/17/2015 64600 11/20/2015 61979 11/21/2015 61980 11/22/2015 63012 12/9/2015 63014 12/18/2015 63231 12/19/2015 65902 12/24/2015 63993 1/16/2016 57069 5/21/2016 57629 6/24/2016 58257 7/20/2016 58321 7/24/2016 67609 7/24/2016 58463 7/25/2016 77994 7/30/2016 58936 8/21/2016 58938 8/22/2016 59058 8/23/2016 68288 9/3/2016 69711 9/18/2016 68756 9/22/2016 70300 9/23/2016 70300 9/23/2016 68287 9/24/2016 70569 9/24/2016 68757 9/25/2016 70769 9/28/2016 70299 10/22/2016 71130 12/17/2016 72509 1/15/2017 72796 1/16/2017 72081 1/21/2017 72319 1/21/2017 73779 1/23/2017 73412 3/21/2017 72961 3/22/2017 73089 3/23/2017 73549 4/15/2017 74273 4/19/2017 74274 4/20/2017 74275 4/23/2017 74276 4/23/2017 74410 4/24/2017 76487 4/24/2017 76884 4/24/2017 74823 5/23/2017 74824 5/23/2017 75046 5/24/2017 75205 5/24/2017 75352 6/21/2017 75675 6/21/2017 76278 7/19/2017 76277 7/24/2017 76885 7/24/2017 78352 9/14/2017 78133 9/29/2017 78952 11/21/2017 80544 1/18/2018 79605 1/23/2018 70570 1/24/2018 81269 2/14/2018  60229 5/18/2014 61713 8/5/2014 62412 10/12/2014 62622 12/4/2014  63424 12/3/2014 63758 1/18/2015 64012 12/11/2014 66920 2/21/2015 67462 4/4/2015 68759 4/5/2015 69468 9/28/2015 70973 11/20/2015 72097 12/24/2015 73763 3/9/2016 74313 4/25/2016 75999 5/24/2016 77194 11/30/2016 79795 2/26/2017     
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information ContactVicki 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
ActionAligned 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 Commerce5723 kits
DistributionNationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
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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