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

Extremity Pack, Kit number AMS2726, AMS2937, AMS3240 recalled

Windstone Medical Packaging is recalling Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, 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: 59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015 61013 9/14/2015 64817 10/10/2015 61618 10/15/2015 61383 10/18/2015 64593 10/19/2015 64969 11/3/2015 65776 11/5/2015 64394 11/14/2015 63778 11/15/2015 65580 11/16/2015 61938 11/17/2015 62567 11/18/2015 61626 11/20/2015 66917 11/21/2015 61343 11/22/2015 66393 11/23/2015 62154 11/23/2015 66584 11/26/2015 63230 12/18/2015 66183 12/24/2015 64380 1/4/2016 63989 1/7/2016 63404 1/9/2016 78771 1/9/2016 63992 1/11/2016 64696 1/13/2016 64395 1/14/2016 63779 1/18/2016 73914 3/2/2016 73298 3/16/2016 73714 3/23/2016 56866 5/22/2016 57094 5/23/2016 57068 5/24/2016 77013 6/4/2016 70913 6/6/2016 74518 6/8/2016 57067 6/10/2016 71703 6/14/2016 57216 6/19/2016 76121 6/21/2016 57511 6/22/2016 67763 7/1/2016 69284 7/16/2016 70977 7/17/2016 72321 7/17/2016 58092 7/20/2016 67097 7/23/2016 58319 7/25/2016 77988 7/30/2016 77053 7/30/2016 78132 7/30/2016 77721 7/30/2016 58935 8/21/2016 59057 8/22/2016 57588 8/23/2016 72894 8/25/2016 68286 8/25/2016 59210 8/28/2016 70323 9/11/2016 68755 9/22/2016 69925 9/22/2016 70567 9/24/2016 68888 9/26/2016 70568 9/28/2016 77749 10/21/2016 70298 10/23/2016 69708 10/24/2016 71084 10/28/2016 69471 10/31/2016 69083 11/24/2016 71424 12/11/2016 72789 1/10/2017 72318 1/10/2017 70981 1/21/2017 72960 1/21/2017 73548 1/22/2017 73097 3/13/2017 73917 4/18/2017 74272 4/24/2017 74822 5/14/2017 75045 5/24/2017 74474 5/25/2017 75351 6/20/2017 77597 7/19/2017 75822 7/23/2017 76486 7/27/2017 74084 8/4/2017 76956 8/7/2017 79077 9/10/2017 78131 9/19/2017 77601 10/9/2017 77531 10/10/2017 78761 11/5/2017 78757 11/9/2017 79263 11/23/2017 78470 1/5/2018 79339 1/16/2018 80751 1/23/2018 79337 1/25/2018 79604 2/25/2018 80517 2/25/2018

Quantity recalled3829 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-0183-2017
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

Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 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 Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A recalled?

Yes. Windstone Medical Packaging recalled Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0183-2017.

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: 59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015 61013 9/14/2015 64817 10/10/2015 61618 10/15/2015 61383 10/18/2015 64593 10/19/2015 64969 11/3/2015 65776 11/5/2015 64394 11/14/2015 63778 11/15/2015 65580 11/16/2015 61938 11/17/2015 62567 11/18/2015 61626 11/20/2015 66917 11/21/2015 61343 11/22/2015 66393 11/23/2015 62154 11/23/2015 66584 11/26/2015 63230 12/18/2015 66183 12/24/2015 64380 1/4/2016 63989 1/7/2016 63404 1/9/2016 78771 1/9/2016 63992 1/11/2016 64696 1/13/2016 64395 1/14/2016 63779 1/18/2016 73914 3/2/2016 73298 3/16/2016 73714 3/23/2016 56866 5/22/2016 57094 5/23/2016 57068 5/24/2016 77013 6/4/2016 70913 6/6/2016 74518 6/8/2016 57067 6/10/2016 71703 6/14/2016 57216 6/19/2016 76121 6/21/2016 57511 6/22/2016 67763 7/1/2016 69284 7/16/2016 70977 7/17/2016 72321 7/17/2016 58092 7/20/2016 67097 7/23/2016 58319 7/25/2016 77988 7/30/2016 77053 7/30/2016 78132 7/30/2016 77721 7/30/2016 58935 8/21/2016 59057 8/22/2016 57588 8/23/2016 72894 8/25/2016 68286 8/25/2016 59210 8/28/2016 70323 9/11/2016 68755 9/22/2016 69925 9/22/2016 70567 9/24/2016 68888 9/26/2016 70568 9/28/2016 77749 10/21/2016 70298 10/23/2016 69708 10/24/2016 71084 10/28/2016 69471 10/31/2016 69083 11/24/2016 71424 12/11/2016 72789 1/10/2017 72318 1/10/2017 70981 1/21/2017 72960 1/21/2017 73548 1/22/2017 73097 3/13/2017 73917 4/18/2017 74272 4/24/2017 74822 5/14/2017 75045 5/24/2017 74474 5/25/2017 75351 6/20/2017 77597 7/19/2017 75822 7/23/2017 76486 7/27/2017 74084 8/4/2017 76956 8/7/2017 79077 9/10/2017 78131 9/19/2017 77601 10/9/2017 77531 10/10/2017 78761 11/5/2017 78757 11/9/2017 79263 11/23/2017 78470 1/5/2018 79339 1/16/2018 80751 1/23/2018 79337 1/25/2018 79604 2/25/2018 80517 2/25/2018

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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