Basic Face Kit recall: Sterility Concern
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
Why was Basic Face Kit 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: 57202 6/5/2016 57594 7/18/2016 58486 8/2/2016 58745 8/27/2016 59099 3/1/2015 59975 7/18/2015 60444 9/13/2015 60705 8/3/2015 61043 8/20/2015 61552 11/27/2015 62834 11/7/2015 63155 11/27/2015 63156 1/2/2016 64068 11/23/2015 64504 11/10/2015 65556 11/9/2015 65855 11/6/2015 66687 11/26/2015 67232 11/18/2015 67233 8/10/2016 67579 8/22/2016 68618 7/11/2016 68940 9/12/2016 69988 9/23/2016 71297 9/12/2016 71430 12/25/2016 71814 12/13/2016 72034 3/13/2017 73741 4/3/2017 74154 4/26/2017 74893 5/4/2017 75440 5/14/2017 75692 7/12/2017 76228 7/3/2017 76544 7/29/2017 76710 8/29/2017 77124 9/23/2017 79188 9/16/2017 79450 1/9/2018 79755 2/28/2018
- Product
- Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 2266 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)