FDA Device recall Z-0204-2017

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351…

FDA Device
Class II
terminated
Published 2016-10-26

On 2016-10-26 the FDA classified a Class II recall of Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351… 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-0204-2017
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

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. 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 codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 5709… Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328 12/13/2014 64679 12/18/2014 63368 12/20/2014 63799 1/13/2015 66644 2/2/2015 66509 2/14/2015 65777 2/25/2015 65573 2/25/2015 65718 2/28/2015 65875 3/6/2015 65572 3/15/2015 59027 3/26/2015 58692 4/5/2015 68613 4/12/2015 67175 4/14/2015 57249 4/20/2015 68069 4/28/2015 59297 7/3/2015 59538 7/4/2015 59157 7/13/2015 59846 8/2/2015 60663 8/4/2015 60131 8/5/2015 60113 8/6/2015 60132 8/6/2015 70171 8/13/2015 61311 8/18/2015 61435 8/20/2015 59514 8/24/2015 59845 8/31/2015 60605 9/7/2015 60754 9/7/2015 61006 9/7/2015 60722 9/11/2015 61164 9/14/2015 60662 9/20/2015 61479 9/21/2015 68892 9/29/2015 61310 10/16/2015 65295 11/2/2015 71133 11/2/2015 62199 11/5/2015 62600 11/5/2015 62349 11/6/2015 61601 11/6/

code_info

Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 5709…

Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328 12/13/2014 64679 12/18/2014 63368 12/20/2014 63799 1/13/2015 66644 2/2/2015 66509 2/14/2015 65777 2/25/2015 65573 2/25/2015 65718 2/28/2015 65875 3/6/2015 65572 3/15/2015 59027 3/26/2015 58692 4/5/2015 68613 4/12/2015 67175 4/14/2015 57249 4/20/2015 68069 4/28/2015 59297 7/3/2015 59538 7/4/2015 59157 7/13/2015 59846 8/2/2015 60663 8/4/2015 60131 8/5/2015 60113 8/6/2015 60132 8/6/2015 70171 8/13/2015 61311 8/18/2015 61435 8/20/2015 59514 8/24/2015 59845 8/31/2015 60605 9/7/2015 60754 9/7/2015 61006 9/7/2015 60722 9/11/2015 61164 9/14/2015 60662 9/20/2015 61479 9/21/2015 68892 9/29/2015 61310 10/16/2015 65295 11/2/2015 71133 11/2/2015 62199 11/5/2015 62600 11/5/2015 62349 11/6/2015 61601 11/6/

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-0204-2017%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.