Upper Extremity Pack recall: Sterility Concern
Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
Why was Upper Extremity 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: 62892 3/18/2014 61288 3/30/2014 66302 11/8/2015 64646 11/30/2015 68734 12/19/2015 68513 12/31/2015
- Product
- Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 108 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)