Lumbar Laminectomy Pack recall: Sterility Concern
Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
Why was Lumbar Laminectomy 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: 64906 11/3/2015 66041 11/6/2015 62111 11/12/2015 65892 12/22/2015 66759 7/29/2016 69271 9/19/2016 68960 9/26/2016 67958 9/28/2016 70334 1/29/2017 74063 5/15/2017 75454 7/8/2017 80958 8/8/2017 78464 9/14/2017 77100 10/25/2017 79659 1/17/2018
- Product
- Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 249 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)