Plastic Pack recall: Sterility Concern
Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
Why was Plastic 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 Number/ Expiration Date: 58987 3/10/2014 65124 6/13/2014 63594 6/30/2014 65383 7/3/2014 67936 9/16/2014 68657 9/20/2014 67280 9/27/2014 76180 6/10/2016 57602 6/18/2016 78529 7/30/2016 59242 8/27/2016 80645 11/19/2016
- Product
- Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 204 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)