Skip to content
Recall Observatory FDA recall evidence

Device product

Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room

Z-0154-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
288 kits
Official record key
device-enforcement:Z-0154-2017

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: 57223 2/26/2015 58307 4/10/2015 60261 7/17/2015 63765 11/15/2015 64007 7/5/2015 64597 1/6/2016 65800 11/5/2015 70762 10/25/2016 72336 12/9/2016 72759 1/24/2017 73439 1/27/2017 74083 4/25/2017 75079 6/25/2016 77743 9/17/2017 80762 8/2/2017

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.