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Recall Observatory FDA recall evidence

Device product

Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

Z-0152-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
312 kits
Official record key
device-enforcement:Z-0152-2017

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 NumbersExpiration Dates: 58626 10/25/2014 61076 5/14/2015 62460 6/4/2015 63884 6/6/2015 63742 6/11/2015 65028 6/12/2015 63220 6/18/2015 66436 11/27/2015 65659 11/30/2015 57175 5/16/2016 67267 5/17/2016 72357 5/25/2016 72480 7/21/2016 78609 1/17/2017

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.