—#149878

Product

Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. 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 Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018

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 #149878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.