Major General Pack recall: Sterility Concern
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Why was Major General 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 58579 8/20/2013 62097 12/4/2013 61593 12/15/2013 59838 12/30/2013 64762 12/31/2013 60645 1/13/2014 59179 1/14/2014 67196 1/31/2014 65990 2/28/2014 63190 9/15/2014 62540 9/20/2014 67875 9/28/2014 65484 9/30/2014 69395 5/2/2016 56674 5/29/2016 71054 6/3/2016 57460 6/14/2016 68944 6/20/2016 70475 8/10/2016
- Product
- Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 852 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)