Facial Tray recall: Sterility Concern
Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
Why was Facial 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: 59208 11/3/2015 66913 11/9/2015 64949 1/1/2016 63581 1/4/2016 56990 6/19/2016 58800 8/22/2016 68611 9/11/2016 69745 9/17/2016 73553 1/27/2017 70679 3/22/2017 73768 4/11/2017 74539 6/19/2017 75798 9/19/2017 79480 1/2/2018 80615 2/23/2018
- Product
- Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 282 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)