FDAClass IIMarch 8, 2017

Upper Torso Tray recall: Sterility Concern

Upper Torso Tray, part number PSS1554(B

Why was Upper Torso 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 100669, 7/6/2019 83865, 5/24/2018 85348, 7/3/2018 87940, 8/12/2018 88676, 8/12/2018 89622, 9/4/2018 95648, 12/5/2018 96352, 2/8/2019 98061, 4/18/2019 98969, 6/18/2019

Product
Upper Torso Tray, part number PSS1554(B
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
222 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