Basin Pack recall: Sterility Concern
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Why was Basin Pack 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: 67015 7/5/2016 67549 8/10/2016 68418 7/7/2016 68820 9/19/2016 68959 9/12/2016 69548 9/20/2016 69852 10/23/2016 70495 10/20/2016 71780 12/11/2016 71957 10/20/2016 71958 1/7/2017 72481 3/15/2017 73643 1/22/2017 73644 4/10/2017 73850 4/23/2017 74062 7/9/2017 76185 7/11/2017 76345 8/31/2017 76673 10/21/2017 77769 10/4/2017 78025 9/22/2017 78741 1/17/2018 80940 8/8/2017
- Product
- Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1243 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)