FDAClass IIOctober 26, 2016

Dr Bragg Vein Tray recall: Sterility Concern

Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating…

Why was Dr Bragg Vein Tray 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: 61836 6/30/2013 58821 9/2/2013 60583 11/1/2013 62371 3/8/2014 65618 4/16/2014 64076 4/20/2014 67477 7/11/2014 69351 10/2/2014 69593 12/20/2014 72030 2/2/2016 73144 2/17/2016 72643 2/28/2016 74897 5/31/2016 77971 6/16/2016 76042 6/20/2016 56380 6/25/2016

Product
Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
360 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)
Open FDA enforcement record Latest recalls