Transvaginal Pack recall: Sterility Concern
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
Why was Transvaginal Pack recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1780 kits
- Distribution
- Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)