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Recall Observatory FDA recall evidence

Device product

Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

Z-0283-2017

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-0283-2017

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: 60996 8/3/2015 59383 8/20/2015 63706 11/11/2015 65733 11/30/2015 65404 12/26/2015 58253 7/23/2016 58476 8/30/2016 70957 11/6/2016 71370 12/11/2016 72254 1/8/2017 76639 11/19/2017

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.