—#149650

Product

Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. 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: 59278 10/2/2013 58407 10/14/2013 62436 12/4/2013 62922 12/18/2013 60740 5/20/2014 63467 6/2/2014 62067 6/7/2014 64703 6/10/2014 61619 6/14/2014 64110 6/14/2014 63539 6/29/2014 65271 7/8/2014 65364 7/11/2014 65837 7/31/2014 70246 9/3/2014 70351 9/4/2014 69850 9/7/2014 67400 9/11/2014 69434 9/18/2014 71639 9/18/2014 68310 9/30/2014 72944 10/1/2014 71948 10/9/2014 71949 10/22/2014 65894 2/7/2015 68624 3/12/2015 77600 8/12/2015 76292 8/14/2015 72862 10/5/2015 73989 10/7/2015 67704 12/5/2015 73680 1/3/2016 74974 1/7/2016 76004 1/9/2016 75570 1/17/2016 73628 1/24/2016 73982 2/3/2016 74027 2/24/2016 74377 3/26/2016 75655 3/29/2016 79047 4/5/2016 78542 4/14/2016 78888 4/27/2016 77381 4/30/2016 57192 5/30/2016 57138 6/4/2016 78207 6/20/2016 71656 8/3/2016 75175 8/19/2016 77224 8/23/2016 74582 9/9/2016 78973 10/28/2016 79324 11/16/2016 79137 11/25/2016

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 #149650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.