Set-Up Pack recall: Sterility Concern
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
Why was Set-Up 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: 67723 11/19/2015 61928 11/20/2015 56692 7/19/2016 67757 7/22/2016 58305 8/6/2016 58345 8/14/2016 69798 9/14/2016 69922 9/16/2016 69923 9/29/2016 58346 10/4/2016 70578 10/11/2016 68747 10/12/2016 69280 10/23/2016 70579 12/5/2016 70580 12/26/2016 70988 3/23/2017 73558 4/24/2017 74320 5/24/2017 74472 5/25/2017 75989 7/16/2017 77190 7/21/2017 76466 7/22/2017 74850 7/23/2017 76890 7/23/2017 75368 7/30/2017 76891 8/4/2017 76903 8/10/2017 77517 8/29/2017 77987 9/5/2017 77361 10/10/2017 78110 1/9/2018 78111 2/6/2018
- Product
- Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 2225 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)