FDAClass IIMarch 8, 2017

Basic Tray recall: Sterility Concern

Basic Tray, part number PSS1559(A

Why was Basic 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 101652, 10/27/2019 87941, 9/23/2018 88545, 11/7/2018 88823, 12/2/2018 95649, 1/4/2019 96354, 1/18/2019 96815, 6/17/2019 97613, 4/18/2020

Product
Basic Tray, part number PSS1559(A
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
69 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