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FDAFDA · Food and drugs·Recall number Z-0238-2017

Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room

Published October 26, 2016 · Recall initiated: April 22, 2015

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Windstone Medical Packaging, Inc.
Distributor
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Lot
Lot Numbers/ Expiration Dates: 58414 8/13/2013 62931 12/9/2013 60184 12/29/2013 59455 1/9/2014 61163 1/21/2014 66804 1/31/2014 65169 2/28/2014 67878 9/11/2014 62190 9/26/2014 64342 9/30/2014 68948 5/10/2016 70180 5/16/2016 57028 5/30/2016 71059 6/4/2016 57611 7/2/2016
Risk classification
Class II
Area (FDA)
device
Country
United States

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