FDAClass IIOctober 26, 2016

Minor Arthroscopy Pack recall: Sterility Concern

Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room

Why was Minor Arthroscopy 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: 58414 8/13/2013 62931 12/9/2013 60184 12/29/2013 59455 1/9/2014 61163 1/21/2014 66804 1/31/2014 65169 2/28/2014 67878 9/11/2014 62190 9/26/2014 64342 9/30/2014 68948 5/10/2016 70180 5/16/2016 57028 5/30/2016 71059 6/4/2016 57611 7/2/2016

Product
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
356 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