General Surgery Pack recall: Sterility Concern
General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
Why was General Surgery 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: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015 63873 1/24/2016 66910 5/30/2016 72335 7/8/2016 72751 7/25/2016 79224 9/10/2017 75804 10/9/2017 79488 1/9/2018
- Product
- General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 168 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)