Upper Torso Tray recall: Sterility Concern
Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
Why was Upper Torso 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: 58440 12/26/2014 57416 2/5/2015 56848 2/23/2015 59052 5/17/2015 58812 5/28/2015 63227 7/20/2015 61936 8/28/2015 59666 10/14/2015 65111 10/20/2015 64230 11/10/2015 65410 12/11/2015 66232 5/19/2016 67772 7/9/2016 57871 7/12/2016 68610 9/20/2016 78517 9/30/2016 70880 10/28/2016 71119 12/14/2016 74426 12/24/2016 73427 1/22/2017 72781 1/30/2017 73810 3/18/2017 78127 8/18/2017 79916 9/20/2017
- Product
- Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 546 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)