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U.S. Department of Health and Human Services

Class 2 Device Recall Laparotomy Pack

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  Class 2 Device Recall Laparotomy 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-0222-2017
Recall Event ID 71968
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A.
convenience custom kits used for general surgery in hospital operating room
Code Information Lot numbers/Expiration dates:  57968 3/10/2014 58335 3/26/2014 57096 3/30/2014 59915 6/16/2014 58966 6/19/2014 61731 8/7/2014 63240 8/21/2014 61024 9/17/2014 61499 9/22/2014 63588 2/11/2015 65772 2/25/2015 65779 2/26/2015 64225 2/28/2015 65239 3/20/2015 66645 7/20/2015 68070 8/4/2015 58830 8/5/2015 68893 8/12/2015 68265 8/17/2015 59541 8/30/2015 60650 9/1/2015 69806 10/6/2015 59840 11/9/2015 63811 1/18/2016 73766 2/2/2016 72807 2/7/2016 71917 2/9/2016 73424 2/15/2016 72515 2/15/2016 73401 2/15/2016 72806 2/28/2016 74679 4/11/2016 74853 5/15/2016 71892 6/1/2016 74680 6/1/2016 71726 6/11/2016 72656 6/16/2016 57461 6/23/2016 57174 7/11/2016 58034 7/11/2016 76085 8/4/2016 58492 8/8/2016 58502 8/13/2016 76923 8/24/2016 78168 9/5/2016 79609 9/9/2016 78573 9/27/2016 70930 9/28/2016 71324 10/19/2016 73071 1/29/2017 74331 5/1/2017 75004 5/4/2017 75545 7/16/2017 77174 7/20/2017 79653 8/7/2017 78409 8/12/2017 79636 1/9/2019 
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 1528 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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