Dr. Landi EVLT Pack recall: Sterility Concern
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
Why was Dr. Landi EVLT 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 Numbers/Expiration Dates: 59444 7/10/2014 60056 8/8/2014 60425 8/20/2014 60967 11/3/2014 59000 1/13/2015 63464 2/9/2015 64533 2/25/2015 61267 2/27/2015 63798 3/30/2015 65629 7/30/2015 66813 10/21/2015 69765 11/2/2015 69528 11/18/2015 67138 11/19/2015 67399 1/2/2016 67989 2/6/2016 70374 3/17/2016 69766 3/30/2016 71447 4/18/2016 72241 5/15/2016 57208 7/24/2016 75250 8/7/2016 58621 8/10/2016 73977 8/11/2016 73190 8/12/2016 73277 8/23/2016 74340 8/26/2016 78679 10/24/2016 79046 10/25/2016 75603 1/26/2017 76940 2/11/2017 76159 2/14/2017 78015 6/16/2017 76568 6/26/2017 79824 7/25/2017 81121 8/13/2017 68922
- Product
- Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 2048 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)