FDAClass IIOctober 26, 2016

Head and Neck Pack recall: Sterility Concern

Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating…

Why was Head and Neck 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: 62890 3/28/2014 61286 5/28/2014 61286 5/28/2014 59473 4/20/2015 59560 7/3/2015 60355 7/17/2015 60356 7/22/2015 60357 7/23/2015 60452 8/29/2015 61629 9/3/2015 60755 10/3/2015 61443 10/19/2015 65058 11/1/2015 64558 11/6/2015 65918 11/13/2015 66516 11/15/2015 65281 11/16/2015 61558 11/17/2015 62751 11/21/2015 64660 11/21/2015 62752 11/25/2015 61971 11/29/2015 64624 11/30/2015 72235 12/3/2015 67959 12/12/2015 69436 12/16/2015 68587 12/21/2015 69183 12/21/2015 71969 12/21/2015 65701 12/23/2015 67341 12/26/2015 70809 12/26/2015 62944 1/8/2016 72839 5/8/2016 57471 6/5/2016 57615 6/26/2016 68222 7/5/2016 58757 8/9/2016 67888 8/10/2016 59028 8/15/2016 68864 9/19/2016 69701 10/6/2016 69063 10/10/2016 69678 10/23/2016 69679 10/26/2016

Product
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
2004 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