—#149769

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

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Timeline

Recall initiated: 2015-04-22
Terminated: 2016-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149769. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.