CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539 recalled

Windstone Medical Packaging is recalling Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, distributed nationwide in the US. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

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Lot, batch or date codesLot 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 11/6/2015 64476 11/6/2015 66318 11/6/2015 61521 11/7/2015 66319 11/8/2015 65296 11/10/2015 64850 11/11/2015 64477 11/11/2015 62200 11/13/2015 62943 11/13/2015 70754 11/13/2015 62903 11/14/2015 63199 11/15/2015 61602 11/23/2015 61642 11/26/2015 62425 11/27/2015 62546 11/27/2015 66795 11/27/2015 61603 11/29/2015 65598 11/30/2015 65700 11/30/2015 72347 12/4/2015 72783 12/15/2015 72804 12/21/2015 65699 12/23/2015 65294 12/26/2015 65195 12/27/2015 64632 1/2/2016 73047 1/6/2016 64291 1/7/2016 64349 1/8/2016 63430 1/9/2016 65019 1/12/2016 64475 1/16/2016 63200 1/18/2016 63711 1/22/2016 63948 1/25/2016 64042 1/30/2016 63984 1/30/2016 67589 2/5/2016 69258 2/5/2016 69459 2/5/2016 71210 2/11/2016 66794 2/14/2016 68862 2/14/2016 69603 2/20/2016 69604 2/20/2016 67588 2/24/2016 74530 2/25/2016 73860 3/6/2016 74555 3/10/2016 68572 3/13/2016 68863 3/22/2016 69062 3/26/2016 66552 4/4/2016 70511 4/6/2016 71878 4/8/2016 70512 4/10/2016 70267 4/14/2016 70268 4/16/2016 74731 4/18/2016 69605 4/20/2016 69866 4/23/2016 70510 4/24/2016 73286 4/24/2016 74443 4/25/2016 77115 5/10/2016 75128 5/17/2016 75800 5/22/2016 56502 5/23/2016 56722 5/30/2016 57013 6/7/2016 56723 6/12/2016 57469 6/18/2016 57573 6/27/2016 71877 7/2/2016 71435 7/4/2016 66796 7/5/2016 57790 7/8/2016 57774 7/9/2016 71073 7/13/2016 66551 7/14/2016 71879 7/15/2016 58288 7/16/2016 57645 7/17/2016 77366 7/17/2016 57945 7/18/2016 71437 7/18/2016 71982 7/22/2016 69061 7/26/2016 71268 7/26/2016 71981 7/29/2016 78379 7/29/2016 77328 7/30/2016 78043 7/30/2016 78160 7/30/2016 58451 7/31/2016 58067 8/2/2016 71436 8/5/2016 67206 8/11/2016 58275 8/14/2016 58587 8/30/2016 78339 8/31/2016 75047 9/2/2016 79834 10/12/2016 81141 10/31/2016 78837 11/5/2016 80914 11/6/2016 60593 11/26/2016 77334 7/20/2017 76451 7/22/2017 77342 10/1/2017

Quantity recalled8132 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0204-2017
FDA event ID: 71968
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2015
FDA classified: 20 Oct 2016
Reported: 26 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

22 Apr 2015	Recall initiated by company
20 Oct 2016	Classified by FDA	+547 days
26 Oct 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Nationwide California Florida Georgia Illinois Kansas Louisiana Michigan New Jersey Nevada Texas Virginia Wyoming

Questions about this recall

Is Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213 recalled?

Yes. Windstone Medical Packaging recalled Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213 on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0204-2017.

Why was it recalled?

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.

Which lots are affected?

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 11/6/2015 64476 11/6/2015 66318 11/6/2015 61521 11/7/2015 66319 11/8/2015 65296 11/10/2015 64850 11/11/2015 64477 11/11/2015 62200 11/13/2015 62943 11/13/2015 70754 11/13/2015 62903 11/14/2015 63199 11/15/2015 61602 11/23/2015 61642 11/26/2015 62425 11/27/2015 62546 11/27/2015 66795 11/27/2015 61603 11/29/2015 65598 11/30/2015 65700 11/30/2015 72347 12/4/2015 72783 12/15/2015 72804 12/21/2015 65699 12/23/2015 65294 12/26/2015 65195 12/27/2015 64632 1/2/2016 73047 1/6/2016 64291 1/7/2016 64349 1/8/2016 63430 1/9/2016 65019 1/12/2016 64475 1/16/2016 63200 1/18/2016 63711 1/22/2016 63948 1/25/2016 64042 1/30/2016 63984 1/30/2016 67589 2/5/2016 69258 2/5/2016 69459 2/5/2016 71210 2/11/2016 66794 2/14/2016 68862 2/14/2016 69603 2/20/2016 69604 2/20/2016 67588 2/24/2016 74530 2/25/2016 73860 3/6/2016 74555 3/10/2016 68572 3/13/2016 68863 3/22/2016 69062 3/26/2016 66552 4/4/2016 70511 4/6/2016 71878 4/8/2016 70512 4/10/2016 70267 4/14/2016 70268 4/16/2016 74731 4/18/2016 69605 4/20/2016 69866 4/23/2016 70510 4/24/2016 73286 4/24/2016 74443 4/25/2016 77115 5/10/2016 75128 5/17/2016 75800 5/22/2016 56502 5/23/2016 56722 5/30/2016 57013 6/7/2016 56723 6/12/2016 57469 6/18/2016 57573 6/27/2016 71877 7/2/2016 71435 7/4/2016 66796 7/5/2016 57790 7/8/2016 57774 7/9/2016 71073 7/13/2016 66551 7/14/2016 71879 7/15/2016 58288 7/16/2016 57645 7/17/2016 77366 7/17/2016 57945 7/18/2016 71437 7/18/2016 71982 7/22/2016 69061 7/26/2016 71268 7/26/2016 71981 7/29/2016 78379 7/29/2016 77328 7/30/2016 78043 7/30/2016 78160 7/30/2016 58451 7/31/2016 58067 8/2/2016 71436 8/5/2016 67206 8/11/2016 58275 8/14/2016 58587 8/30/2016 78339 8/31/2016 75047 9/2/2016 79834 10/12/2016 81141 10/31/2016 78837 11/5/2016 80914 11/6/2016 60593 11/26/2016 77334 7/20/2017 76451 7/22/2017 77342 10/1/2017

Where was it sold?

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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