FDAClass IIMarch 8, 2017

Minor Procedure Pack recall: Sterility Concern

Minor Procedure Pack, part number AMS4799

Why was Minor Procedure 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 100253, 3/31/2018 88213, 4/30/2017 88671, 4/13/2017 88876, 4/22/2017 89097, 4/30/2017 89205, 4/15/2017 94555, 3/31/2017 94588, 3/31/2017 95305, 3/31/2017 96331, 10/26/2017 97150, 11/30/2017 98711, 11/30/2017

Product
Minor Procedure Pack, part number AMS4799
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
365 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