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Class 2 Device Recall Head and Neck Pack |
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Date Initiated by Firm |
April 22, 2015 |
Create Date |
October 20, 2016 |
Recall Status1 |
Terminated 3 on October 25, 2016 |
Recall Number |
Z-0206-2017 |
Recall Event ID |
71968 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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Product |
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
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Code Information |
Lot Numbers/ Expiration Dates: 62890 3/28/2014 61286 5/28/2014 61286 5/28/2014 59473 4/20/2015 59560 7/3/2015 60355 7/17/2015 60356 7/22/2015 60357 7/23/2015 60452 8/29/2015 61629 9/3/2015 60755 10/3/2015 61443 10/19/2015 65058 11/1/2015 64558 11/6/2015 65918 11/13/2015 66516 11/15/2015 65281 11/16/2015 61558 11/17/2015 62751 11/21/2015 64660 11/21/2015 62752 11/25/2015 61971 11/29/2015 64624 11/30/2015 72235 12/3/2015 67959 12/12/2015 69436 12/16/2015 68587 12/21/2015 69183 12/21/2015 71969 12/21/2015 65701 12/23/2015 67341 12/26/2015 70809 12/26/2015 62944 1/8/2016 72839 5/8/2016 57471 6/5/2016 57615 6/26/2016 68222 7/5/2016 58757 8/9/2016 67888 8/10/2016 59028 8/15/2016 68864 9/19/2016 69701 10/6/2016 69063 10/10/2016 69678 10/23/2016 69679 10/26/2016 |
Recalling Firm/ Manufacturer |
Windstone Medical Packaging, Inc. 1602 4th Ave N Billings MT 59101-1521
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For Additional Information Contact |
Vicki Davis 406-259-6387
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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.
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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 |
2004 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
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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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