Skip to content
Recall Observatory FDA recall evidence

Device product

HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room

Z-0209-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
360 kits
Official record key
device-enforcement:Z-0209-2017

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: 67433 8/1/2016 71250 9/12/2016 69748 9/20/2016 71417 1/3/2017 72802 4/23/2017 74796 7/14/2017 78203 8/5/2017 76919 8/16/2017 79432 2/25/2018

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.