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

Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868 recalled

Windstone Medical Packaging is recalling Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, 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 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 2/21/2015 69056 11/26/2017 69067 9/20/2016 69191 9/16/2016 69343 9/5/2016 69344 9/11/2016 69345 9/14/2016 69549 9/20/2016 69646 12/24/2016 69893 3/29/2017 70157 9/12/2016 70176 12/12/2015 70966 7/11/2016 70970 10/10/2016 71156 12/27/2016 71450 2/13/2015 71634 1/5/2017 71634 1/5/2017 71788 10/20/2016 71945 1/3/2017 71955 2/7/2015 71987 1/21/2017 72112 3/24/2017 72306 1/7/2017 72490 3/21/2017 72616 3/23/2017 72640 3/12/2017 72978 3/1/2017 72978 3/1/2017 73191 8/21/2016 73203 3/8/2017 73204 4/20/2017 73428 4/4/2017 73645 1/22/2017 73646 4/5/2017 73826 7/27/2017 73933 4/13/2017 73933 4/13/2017 73934 5/3/2017 74061 1/16/2017 74442 4/20/2017 74460 5/9/2017 75094 5/4/2017 75255 6/21/2017 75455 6/25/2016 75646 7/16/2017 75745 6/27/2016 75830 7/9/2017 75902 7/11/2017 76026 7/2/2017 76034 7/23/2017 76083 4/23/2017 76141 7/9/2017 76142 4/23/2017 76152 7/30/2016 76161 8/30/2017 76236 7/15/2016 76662 10/25/2017 76680 8/29/2017 76917 8/5/2017 76948 8/30/2017 77315 10/1/2017 77434 8/14/2017 77518 9/27/2017 77771 10/9/2017 77845 8/23/2017 78027 9/2/2017 78325 8/26/2017 78337 11/9/2017 78641 9/2/2017 78743 9/19/2017 78879 11/2/2017 78980 1/6/2018 79248 9/10/2017 79315 1/17/2018 79497 1/2/2018 79657 2/2/2018 80442 2/26/2018 80608 1/19/2018 80916 1/9/2018

Quantity recalled6381 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-0147-2017
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

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

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 Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608 recalled?

Yes. Windstone Medical Packaging recalled Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608 on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0147-2017.

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 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 2/21/2015 69056 11/26/2017 69067 9/20/2016 69191 9/16/2016 69343 9/5/2016 69344 9/11/2016 69345 9/14/2016 69549 9/20/2016 69646 12/24/2016 69893 3/29/2017 70157 9/12/2016 70176 12/12/2015 70966 7/11/2016 70970 10/10/2016 71156 12/27/2016 71450 2/13/2015 71634 1/5/2017 71634 1/5/2017 71788 10/20/2016 71945 1/3/2017 71955 2/7/2015 71987 1/21/2017 72112 3/24/2017 72306 1/7/2017 72490 3/21/2017 72616 3/23/2017 72640 3/12/2017 72978 3/1/2017 72978 3/1/2017 73191 8/21/2016 73203 3/8/2017 73204 4/20/2017 73428 4/4/2017 73645 1/22/2017 73646 4/5/2017 73826 7/27/2017 73933 4/13/2017 73933 4/13/2017 73934 5/3/2017 74061 1/16/2017 74442 4/20/2017 74460 5/9/2017 75094 5/4/2017 75255 6/21/2017 75455 6/25/2016 75646 7/16/2017 75745 6/27/2016 75830 7/9/2017 75902 7/11/2017 76026 7/2/2017 76034 7/23/2017 76083 4/23/2017 76141 7/9/2017 76142 4/23/2017 76152 7/30/2016 76161 8/30/2017 76236 7/15/2016 76662 10/25/2017 76680 8/29/2017 76917 8/5/2017 76948 8/30/2017 77315 10/1/2017 77434 8/14/2017 77518 9/27/2017 77771 10/9/2017 77845 8/23/2017 78027 9/2/2017 78325 8/26/2017 78337 11/9/2017 78641 9/2/2017 78743 9/19/2017 78879 11/2/2017 78980 1/6/2018 79248 9/10/2017 79315 1/17/2018 79497 1/2/2018 79657 2/2/2018 80442 2/26/2018 80608 1/19/2018 80916 1/9/2018

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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