Laparoscopic Pack recall: Sterility Concern
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
Why was Laparoscopic 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: 62086 11/7/2015 65280 11/8/2015 62087 11/17/2015 65736 11/30/2015 64547 1/6/2016 67957 7/7/2016 67016 7/16/2016 67697 8/9/2016 69435 9/18/2016 70253 9/23/2016 70497 10/18/2016 70156 10/31/2016 70808 12/13/2016 71959 1/14/2017 73320 3/5/2017 72888 3/24/2017 73333 5/7/2017 75288 5/11/2017 76049 7/20/2017 78640 8/12/2017 78151 8/18/2017 76946 8/31/2017 77686 10/8/2017 77310 10/24/2017 69018 12/10/2017 78978 1/20/2018
- Product
- Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1290 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)