FDA Device recall Z-1363-2017

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

FDA Device
Class II
terminated
Published 2017-03-08

On 2017-03-08 the FDA classified a Class II recall of Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS… by Windstone Medical Packaging, citing 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 sterili….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1363-2017
Classification	Class II
Status	terminated
Initiated	2017-01-11
Published	2017-03-08
Last updated	2026-09-13 11:54 UTC
Company	Windstone Medical Packaging
Distribution	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, WA

Product

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A

Reason

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.

Identifiers

code_info	Lot number and expiration date 83685, 5/17/2018 84193, 5/20/2018 84520, 5/25/2018 84823, 6/30/2018 84892, 6/16/2… 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

code_info

Lot number and expiration date 83685, 5/17/2018 84193, 5/20/2018 84520, 5/25/2018 84823, 6/30/2018 84892, 6/16/2…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1363-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.