FDAClass IIOctober 26, 2016

Eye Plastic Tray recall: Sterility Concern

Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room

Why was Eye Plastic 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 56700 2/25/2014 57515 4/17/2014 62330 8/13/2014 61942 8/29/2014 59216 10/8/2014 63015 1/2/2015 62624 1/6/2015 68055 6/9/2015 66922 6/26/2015 68289 8/28/2015 68448 10/13/2015 72101 11/18/2015 72971 2/28/2016 75676 5/16/2016 76488 9/4/2016 78162 11/13/2016 79264 1/6/2017

Product
Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
720 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