FDAClass IIMarch 8, 2017

Eye Plastic Tray recall: Sterility Concern

Eye Plastic Tray, part number PSS1931(A

Why was Eye Plastic Tray recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits 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 number and expiration date 84566, 3/8/2017 85861, 7/5/2017 86513, 8/27/2017 88308, 11/30/2017 88550, 11/12/2017 88986, 11/1/2017 96822, 2/17/2018 97615, 2/5/2018 97993, 7/9/2018

Product
Eye Plastic Tray, part number PSS1931(A
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
310 kits
Distribution
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Recall date
March 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls