—#149874

Product

Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 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: 61268 4/17/2014 58664 4/10/2015 59825 8/30/2015 61858 11/9/2015 64825 11/10/2015 64826 11/15/2015 66761 11/20/2015 64827 11/21/2015 63483 11/23/2015 59800 11/24/2015 63482 12/6/2015 62873 12/18/2015 65631 12/30/2015 64536 1/5/2016 63481 1/6/2016 63800 1/7/2016 66762 2/5/2016 66763 3/1/2016 67345 6/17/2016 75666 6/25/2016 68684 6/26/2016 66755 7/5/2016 78206 7/30/2016 67334 8/9/2016 60594 8/19/2016 68146 9/15/2016 69196 9/16/2016 70378 9/27/2016 70812 10/17/2016 71784 10/19/2016 71471 11/6/2016 72148 12/3/2016 71157 12/20/2016 71970 12/21/2016 74621 1/14/2017 72889 1/21/2017 73855 1/30/2017 73854 2/5/2017 72495 2/8/2017 72725 3/5/2017 75398 4/19/2017 74872 4/24/2017 76184 4/27/2017 75108 4/29/2017 74121 5/9/2017 75399 5/16/2017 77316 7/12/2017 77104 7/28/2017 77416 8/3/2017 77417 8/9/2017 77407 8/24/2017 77408 8/24/2017 77775 9/2/2017 78643 10/3/2017 76478 10/25/2017 80532 12/6/2017 79831 12/18/2017 79347 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 #149874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.