FDAClass IIMarch 8, 2017

Podiatry Pack recall: Sterility Concern

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C…

Why was Podiatry 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 83685, 5/17/2018 84193, 5/20/2018 84520, 5/25/2018 84823, 6/30/2018 84892, 6/16/2018 85953, 7/29/2018 85991, 7/15/2018 85992, 7/23/2018 86060, 7/11/2018 86346, 7/30/2018 86419, 8/25/2018 87109, 8/15/2018 87789, 9/23/2018 87886, 10/29/2018 88300, 9/23/2018 88301, 9/30/2018 88313, 9/23/2018 88331, 10/11/2018 88332, 10/22/2018 88333, 10/25/2018 88630, 11/17/2018 88630, 11/17/2018 88707, 11/11/2018 88937, 6/28/2019 89028, 12/13/2018 95275, 1/19/2019 95598, 12/27/2018 95803, 1/11/2019 95989, 1/26/2019 96597, 3/24/2019 96916, 3/5/2019 97452, 3/21/2019 97580, 4/15/2019 97781, 4/22/2019 98022, 5/31/2019 98314, 5/29/2019 98668, 6/11/2019 98908, 7/24/2019 99873, 10/1/2019 99874, 6/4/2019

Product
Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
2018 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