Custom Venous Kit recall: Sterility Concern
Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
Why was Custom Venous 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 Numbers Expiration Dates 57411 5/13/2015 58475 5/14/2015 57820 5/17/2015 60799 8/3/2015 62975 11/14/2015 63103 11/14/2015 62235 11/15/2015 62675 11/25/2015 65935 11/27/2015 60995 11/29/2015 63104 12/14/2015 64487 1/5/2016 63521 1/29/2016 67570 4/30/2016 68694 7/11/2016 69235 7/14/2016 68935 7/18/2016 67788 7/30/2016 70949 9/19/2016 76072 11/2/2016 80515 11/2/2016 74746 11/9/2016 76638 11/25/2016 73892 11/26/2016 75428 11/28/2016 79295 11/30/2016 71620 12/12/2016 70720 1/4/2017 75219 5/31/2017 77663 6/19/2017 78672 8/22/2017
- Product
- Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1584 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)