Extremity Tray recall: Sterility Concern
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
Why was Extremity Tray 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: 59843 3/1/2015 60753 8/17/2015 59894 9/6/2015 65996 11/13/2015 61600 11/28/2015 62117 12/12/2015 64160 1/3/2016 69211 5/5/2016 56959 6/8/2016 57789 7/1/2016 67355 7/5/2016 58586 8/27/2016 69588 10/8/2016 70509 1/6/2017 72551 1/10/2017 76068 7/17/2017 77502 7/17/2017 78140 9/19/2017
- Product
- Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 816 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)