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Recall Observatory FDA recall evidence

Device product

D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room

Z-0169-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
592 kits
Official record key
device-enforcement:Z-0169-2017

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: 63769 11/20/2015 63004 1/7/2016 64664 1/18/2016 57354 6/27/2016 58304 8/14/2016 70196 12/13/2016 74082 5/15/2017 76454 7/14/2017 74810 7/17/2017 77337 11/3/2017 69835 1/15/2018 79554 1/19/2018

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.