Basic Setup Pack recall: Sterility Concern
Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
Why was Basic Setup 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 60480 9/6/2015 61269 9/2/2015 63468 11/10/2015 65272 11/13/2015 68625 9/14/2016 69999 10/2/2016 70654 10/11/2016 71789 12/10/2016 72154 3/8/2017 73836 5/16/2017 75272 7/18/2017 76643 7/1/2017 77304 10/8/2017 78543 8/30/2017
- Product
- Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 256 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)