—#149756

Product

General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(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: 64285 3/3/2014 61278 3/4/2014 62888 3/28/2014 67339 11/27/2014 64287 10/26/2015 65277 11/1/2015 64286 11/4/2015 65531 11/15/2015 65566 11/20/2015 65215 11/26/2015 70153 12/5/2015 67953 12/7/2015 71459 12/12/2015 69644 12/14/2015 69127 12/16/2015 70377 12/19/2015 67952 12/24/2015 64642 12/26/2015 68630 12/26/2015 71458 12/27/2015 64656 1/5/2016 71965 5/7/2016 72838 5/8/2016 73354 5/12/2016 71966 5/15/2016 68316 9/18/2016 71083 10/28/2016 69577 11/16/2016 71499 12/27/2016 72690 1/14/2017 72222 1/25/2017 73248 3/5/2017 73815 4/30/2017 75445 5/13/2017 75892 7/8/2017 76336 7/17/2017 78746 8/6/2017 80739 8/7/2017 76447 8/7/2017 78102 8/15/2017 78417 9/30/2017 77353 10/1/2017 78847 11/9/2017 78648 1/9/2018 78946 1/25/2018 80448 2/28/2018

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 #149756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.