Basic Kit recall: Sterility Concern
Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
Why was Basic 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: 57495 7/3/2016 57946 6/29/2016 59013 8/22/2016 59014 3/28/2015 60496 9/1/2015 61879 11/6/2015 62950 11/28/2015 64294 1/7/2016 65396 11/3/2015 65981 11/1/2015 67215 7/16/2016 68373 9/4/2016 70215 9/15/2016 71010 10/17/2016 72059 3/21/2017 73446 3/7/2017 73960 4/5/2017 74662 5/9/2017 75137 5/5/2017 75760 7/13/2017 77133 7/17/2017 77727 8/16/2017 78449 9/15/2017 79367 1/25/2018 79939 1/17/2018
- Product
- Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 53 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)