Basic Tray recall: Sterility Concern
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Why was Basic 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: 56958 5/29/2016 56991 6/4/2016 57637 7/5/2016 57788 7/10/2016 59063 1/22/2016 59363 3/24/2015 60073 10/30/2016 60752 10/29/2015 61309 9/27/2015 62116 11/28/2015 62453 11/14/2015 62727 11/5/2015 63987 1/8/2016 64556 1/6/2016 65214 1/1/2016 65698 11/30/2015 66531 8/9/2016 66620 11/9/2015 68220 9/28/2016 68650 9/13/2016 69059 9/22/2016 69210 5/26/2016 69417 9/7/2016 69787 1/29/2017 70198 11/30/2016 70590 9/21/2016 70993 12/6/2016 71368 12/13/2016 71904 3/30/2017 72550 1/10/2017 72914 3/29/2017 73285 7/21/2017 73824 4/5/2017 74175 5/3/2017 75314 5/11/2017 75728 7/3/2017 76171 7/7/2017 76624 8/4/2017 77162 8/10/2017 77576 10/8/2017 77742 10/2/2017 78128 9/30/2017 78139 9/22/2017 79481 1/23/2018
- Product
- Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1599 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)