FDAFDA · Food and drugs·Recall number Z-0278-2017
Transvaginal Pack, Kit number CMP1767 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 Number/ Expiration Date: 59178 4/13/2015 59934 7/12/2015 65288 11/2/2015 62926 11/10/2015 61866 11/11/2015 66049 11/15/2015 62393 11/28/2015 65692 12/22/2015 63808 1/6/2016 64452 1/17/2016 57606 6/7/2016 66520 7/23/2016 57779 8/10/2016 69057 9/3/2016 59004 9/11/2016 67872 9/30/2016 60067 12/27/2016 69452 1/3/2017 72635 1/9/2017 72687 1/17/2017 72841 3/9/2017 72688 3/22/2017 73048 5/21/2017 74873 5/24/2017 74988 7/16/2017 76993 8/14/2017 77250 9/11/2017 80477 1/9/2018 77808 1/16/2018 67027 (no date was provided)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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