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Recall Observatory FDA recall evidence

Device 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

Z-0155-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
1498 kits
Official record key
device-enforcement:Z-0155-2017

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.