FDAClass IIMarch 8, 2017

Dr. Casey Pack recall: Sterility Concern

Dr. Casey Pack, part number AMS4313(A

Why was Dr. Casey Pack 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 89198, 4/22/2018 94965, 3/31/2018 95296, 2/20/2018 96567, 4/18/2018

Product
Dr. Casey Pack, part number AMS4313(A
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
66 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