Skip to content
Recall Observatory FDA recall evidence

Device product

C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room

Z-0158-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
48 kits
Official record key
device-enforcement:Z-0158-2017

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 58647 8/18/2013 60158 10/31/2015 66579 11/28/2015 67412 4/30/2016 68841 1/31/2016 73940 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.