Plastic Kit recall: Sterility Concern
Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
Why was Plastic Kit 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: 58302 3/26/2014 59046 6/9/2014 60228 6/15/2014 60559 6/20/2014 63222 8/14/2014 61004 9/13/2014 61491 9/21/2014 63003 12/11/2014 64005 2/14/2015 63768 2/22/2015 64592 3/18/2015 65494 5/30/2015 67289 6/11/2015 67602 8/14/2015 68438 8/22/2015 68275 8/25/2015 69589 10/22/2015 70504 10/24/2015 71258 12/7/2015 71749 12/19/2015 72506 2/15/2016 72750 2/22/2016 74081 2/24/2016 73436 2/28/2016 56986 5/24/2016 76902 6/20/2016 77188 9/9/2016 77986 9/18/2016 78514 9/19/2016 79246 9/26/2016 80549 10/27/2016
- Product
- Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1164 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)