General Pack I recall: Sterility Concern
General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
Why was General Pack I 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: 59313 4/12/2015 59483 7/22/2015 59876 9/13/2015 61092 9/13/2015 60552 10/29/2015 65936 11/2/2015 61362 11/7/2015 62976 11/8/2015 65432 11/8/2015 66398 11/10/2015 61093 11/15/2015 62301 11/18/2015 62676 12/14/2015 64312 1/6/2016 64793 1/12/2016 64183 1/14/2016 63524 1/17/2016 57212 6/16/2016 57213 7/5/2016 67910 7/15/2016 67594 7/27/2016 58074 8/7/2016 58649 8/30/2016 70167 9/15/2016 67911 9/18/2016 68879 10/9/2016 69319 10/31/2016
- Product
- General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1596 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)