—#149879

Product

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(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 Number/ Expiration Date: 61069 1/5/2015 57470 1/15/2015 64162 1/20/2015 66792 1/31/2015 61312 2/27/2015 66392 2/27/2015 59327 4/24/2015 60099 7/15/2015 61872 7/26/2015 60277 8/24/2015 60278 8/24/2015 61393 9/7/2015 63201 9/15/2015 61394 10/14/2015 62762 11/3/2015 61940 11/17/2015 62155 11/23/2015 64557 11/27/2015 61280 11/27/2015 61279 11/28/2015 61392 11/30/2015 66184 12/24/2015 65278 12/27/2015 63178 1/3/2016 63994 1/13/2016 64601 1/13/2016 64643 1/17/2016 63782 1/23/2016 63783 1/23/2016 73045 1/29/2016 69613 2/19/2016 69677 4/9/2016 70513 4/11/2016 76391 4/13/2016 74109 4/24/2016 57074 5/25/2016 76644 5/30/2016 57513 6/20/2016 71983 7/15/2016 67297 7/20/2016 67764 7/20/2016 58232 7/24/2016 58465 7/25/2016 77327 7/26/2016 77744 7/30/2016 78161 7/30/2016 65887 8/1/2016 67940 8/23/2016 68760 9/22/2016 70301 9/22/2016 70693 10/7/2016 69712 10/26/2016 68631 10/31/2016 71525 12/18/2016 71460 1/3/2017 72471 1/10/2017 72320 1/15/2017 70770 1/21/2017 72628 1/21/2017 73287 1/23/2017 72147 1/24/2017 72387 1/26/2017 72082 1/26/2017 72859 3/9/2017 72963 3/28/2017 73114 3/28/2017 76279 4/24/2017 76886 4/24/2017 74673 5/22/2017 75245 6/21/2017 76449 7/14/2017 77055 7/19/2017 77333 8/11/2017 78762 9/19/2017 78747 9/20/2017 79341 11/19/2017 79919 1/23/2018 73790 (no date was provided)

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 #149879. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.