Minor Tray AMS2685 convenience custom kits used for recall: Sterility Concern
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
Why was Minor Tray AMS2685 convenience custom kits used for 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: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952 3/12/2017 73688 4/5/2017 73599 4/20/2017 74550 5/7/2017 74782 5/22/2017 75650 7/29/2017 80441 8/9/2017 78329 9/23/2017 76679 10/4/2017 78742 1/4/2018
- Product
- Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 600 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)