Body Contour Pack recall: Sterility Concern
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Why was Body Contour 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: 57223 2/26/2015 58307 4/10/2015 60261 7/17/2015 63765 11/15/2015 64007 7/5/2015 64597 1/6/2016 65800 11/5/2015 70762 10/25/2016 72336 12/9/2016 72759 1/24/2017 73439 1/27/2017 74083 4/25/2017 75079 6/25/2016 77743 9/17/2017 80762 8/2/2017
- Product
- Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 288 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)