Laparotomy Kit recall: Sterility Concern
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Why was Laparotomy 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: 57846 11/27/2014 58334 11/16/2014 60660 7/21/2015 61766 7/22/2015 62797 10/20/2015 63414 1/30/2016 66908 11/26/2015 67932 4/9/2016 68546 6/11/2016 71757 9/7/2016 72106 9/2/2016 72622 8/25/2016 73283 8/5/2016 73423 8/13/2016 73765 8/2/2016 74067 8/16/2016 74310 12/8/2016 75360 2/4/2017
- Product
- Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 230 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)