Skip to content
Recall Observatory FDA recall evidence

Device product

Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room

Z-0215-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
390 kits
Official record key
device-enforcement:Z-0215-2017

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: 58289 10/17/2014 60644 2/19/2015 65363 2/28/2015 61474 7/23/2015 65877 11/1/2015 64537 11/30/2015 66998 1/31/2016 68952 1/31/2016 67661 2/29/2016 71625 2/29/2016 70410 4/30/2016 71947 5/31/2016 72877 5/31/2016 57137 6/7/2016 77238 6/30/2016 78143 6/30/2016 73985 8/31/2016 74752 8/31/2016 74973 8/31/2016 76523 8/31/2016

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.