FDA Device recall Z-0147-2017

Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A,…

FDA Device
Class II
terminated
Published 2016-10-26

On 2016-10-26 the FDA classified a Class II recall of Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A,… by Windstone Medical Packaging, citing the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0147-2017
Classification	Class II
Status	terminated
Initiated	2015-04-22
Published	2016-10-26
Last updated	2026-09-13 11:54 UTC
Company	Windstone Medical Packaging
Distribution	US

Product

Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room

Reason

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Identifiers

code_info	Lot Numbers/Expiration Dates: 56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 580… Lot Numbers/Expiration Dates: 56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 58068 7/11/2016 58357 7/31/2016 58588 4/10/2015 59298 3/11/2015 59847 9/13/2015 60274 11/4/2015 60353 7/18/2015 60354 7/22/2015 60649 10/28/2015 60797 11/5/2015 61071 10/3/2015 61873 11/28/2015 62203 11/7/2015 62456 11/28/2015 62945 11/2/2015 63065 9/3/2015 63204 11/11/2015 63665 1/29/2016 64166 1/6/2016 64470 1/13/2016 64559 1/29/2016 64750 1/18/2016 64819 10/11/2015 64976 1/14/2016 65020 6/27/2017 65048 11/1/2015 65116 1/17/2016 65411 11/1/2015 65442 11/15/2015 65737 2/15/2016 65804 2/25/2015 65879 12/22/2015 66321 11/12/2015 66395 6/27/2015 66696 11/4/2015 67207 11/16/2015 67521 8/21/2015 67551 7/23/2016 67694 5/2/2015 67700 7/26/2016 67701 7/4/2016 67810 8/10/2016 67966 7/15/2016 68145 8/28/2016 68387 7/6/2016 68410 9/21/2016 68413 9/25/2015 68710 9/13/2016 68711 9/22/2016 68721 9/18/2016 68822 9/5/2016 68857 2/21/201

code_info

Lot Numbers/Expiration Dates: 56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 580…

Lot Numbers/Expiration Dates: 56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 58068 7/11/2016 58357 7/31/2016 58588 4/10/2015 59298 3/11/2015 59847 9/13/2015 60274 11/4/2015 60353 7/18/2015 60354 7/22/2015 60649 10/28/2015 60797 11/5/2015 61071 10/3/2015 61873 11/28/2015 62203 11/7/2015 62456 11/28/2015 62945 11/2/2015 63065 9/3/2015 63204 11/11/2015 63665 1/29/2016 64166 1/6/2016 64470 1/13/2016 64559 1/29/2016 64750 1/18/2016 64819 10/11/2015 64976 1/14/2016 65020 6/27/2017 65048 11/1/2015 65116 1/17/2016 65411 11/1/2015 65442 11/15/2015 65737 2/15/2016 65804 2/25/2015 65879 12/22/2015 66321 11/12/2015 66395 6/27/2015 66696 11/4/2015 67207 11/16/2015 67521 8/21/2015 67551 7/23/2016 67694 5/2/2015 67700 7/26/2016 67701 7/4/2016 67810 8/10/2016 67966 7/15/2016 68145 8/28/2016 68387 7/6/2016 68410 9/21/2016 68413 9/25/2015 68710 9/13/2016 68711 9/22/2016 68721 9/18/2016 68822 9/5/2016 68857 2/21/201

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-0147-2017%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.