FDAClass IIMarch 8, 2017

Eye Tray recall: Sterility Concern

Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A

Why was Eye 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 100671, 9/28/2019 101398, 10/13/2019 84475, 5/26/2018 86027, 9/2/2018 87239, 9/5/2018 89280, 11/16/2018 95047, 1/24/2019 96991, 6/29/2019

Product
Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(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