Minor Ortho Pack recall: Sterility Concern
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
Why was Minor Ortho 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: 59453 8/2/2013 58726 8/21/2013 62658 12/11/2013 63489 12/17/2013 61162 12/21/2013 60183 12/29/2013 65535 1/31/2014 66430 1/31/2014 66807 1/31/2014 61804 2/7/2014 67876 9/5/2014 64144 9/7/2014 64457 9/30/2014 64909 9/30/2014 69781 5/2/2016 68945 5/10/2016 71058 6/4/2016 57425 6/28/2016
- Product
- Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 352 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)