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

Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B recalled

Windstone Medical Packaging is recalling Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A, distributed nationwide in the US. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers/ Expiration Dates: 66444 2/5/2015 73046 1/1/2016 74702 3/18/2016 73595 4/17/2016 78038 7/30/2016 76691 9/1/2016 78555 9/11/2016 78554 10/19/2016 56085 6/6/2016 59697 8/1/2015 67248 7/16/2016 68753 9/12/2016 69101 9/3/2016 78129 8/23/2017 80761 2/1/2018 60666 10/19/2014 59667 7/19/2015 60265 7/19/2015 60266 7/22/2015 60267 7/24/2015 61386 8/20/2015 60268 8/25/2015 60269 8/26/2015 61384 9/17/2015 61385 9/27/2015 61388 10/13/2015 61389 10/15/2015 65208 10/19/2015 61387 11/7/2015 63013 11/14/2015 65740 11/15/2015 65803 11/17/2015 64600 11/20/2015 61979 11/21/2015 61980 11/22/2015 63012 12/9/2015 63014 12/18/2015 63231 12/19/2015 65902 12/24/2015 63993 1/16/2016 57069 5/21/2016 57629 6/24/2016 58257 7/20/2016 58321 7/24/2016 67609 7/24/2016 58463 7/25/2016 77994 7/30/2016 58936 8/21/2016 58938 8/22/2016 59058 8/23/2016 68288 9/3/2016 69711 9/18/2016 68756 9/22/2016 70300 9/23/2016 70300 9/23/2016 68287 9/24/2016 70569 9/24/2016 68757 9/25/2016 70769 9/28/2016 70299 10/22/2016 71130 12/17/2016 72509 1/15/2017 72796 1/16/2017 72081 1/21/2017 72319 1/21/2017 73779 1/23/2017 73412 3/21/2017 72961 3/22/2017 73089 3/23/2017 73549 4/15/2017 74273 4/19/2017 74274 4/20/2017 74275 4/23/2017 74276 4/23/2017 74410 4/24/2017 76487 4/24/2017 76884 4/24/2017 74823 5/23/2017 74824 5/23/2017 75046 5/24/2017 75205 5/24/2017 75352 6/21/2017 75675 6/21/2017 76278 7/19/2017 76277 7/24/2017 76885 7/24/2017 78352 9/14/2017 78133 9/29/2017 78952 11/21/2017 80544 1/18/2018 79605 1/23/2018 70570 1/24/2018 81269 2/14/2018 60229 5/18/2014 61713 8/5/2014 62412 10/12/2014 62622 12/4/2014 63424 12/3/2014 63758 1/18/2015 64012 12/11/2014 66920 2/21/2015 67462 4/4/2015 68759 4/5/2015 69468 9/28/2015 70973 11/20/2015 72097 12/24/2015 73763 3/9/2016 74313 4/25/2016 75999 5/24/2016 77194 11/30/2016 79795 2/26/2017

Quantity recalled5723 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-0142-2017
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: Surgical Instruments

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

Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(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 Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A recalled?

Yes. Windstone Medical Packaging recalled Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0142-2017.

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: 66444 2/5/2015 73046 1/1/2016 74702 3/18/2016 73595 4/17/2016 78038 7/30/2016 76691 9/1/2016 78555 9/11/2016 78554 10/19/2016 56085 6/6/2016 59697 8/1/2015 67248 7/16/2016 68753 9/12/2016 69101 9/3/2016 78129 8/23/2017 80761 2/1/2018 60666 10/19/2014 59667 7/19/2015 60265 7/19/2015 60266 7/22/2015 60267 7/24/2015 61386 8/20/2015 60268 8/25/2015 60269 8/26/2015 61384 9/17/2015 61385 9/27/2015 61388 10/13/2015 61389 10/15/2015 65208 10/19/2015 61387 11/7/2015 63013 11/14/2015 65740 11/15/2015 65803 11/17/2015 64600 11/20/2015 61979 11/21/2015 61980 11/22/2015 63012 12/9/2015 63014 12/18/2015 63231 12/19/2015 65902 12/24/2015 63993 1/16/2016 57069 5/21/2016 57629 6/24/2016 58257 7/20/2016 58321 7/24/2016 67609 7/24/2016 58463 7/25/2016 77994 7/30/2016 58936 8/21/2016 58938 8/22/2016 59058 8/23/2016 68288 9/3/2016 69711 9/18/2016 68756 9/22/2016 70300 9/23/2016 70300 9/23/2016 68287 9/24/2016 70569 9/24/2016 68757 9/25/2016 70769 9/28/2016 70299 10/22/2016 71130 12/17/2016 72509 1/15/2017 72796 1/16/2017 72081 1/21/2017 72319 1/21/2017 73779 1/23/2017 73412 3/21/2017 72961 3/22/2017 73089 3/23/2017 73549 4/15/2017 74273 4/19/2017 74274 4/20/2017 74275 4/23/2017 74276 4/23/2017 74410 4/24/2017 76487 4/24/2017 76884 4/24/2017 74823 5/23/2017 74824 5/23/2017 75046 5/24/2017 75205 5/24/2017 75352 6/21/2017 75675 6/21/2017 76278 7/19/2017 76277 7/24/2017 76885 7/24/2017 78352 9/14/2017 78133 9/29/2017 78952 11/21/2017 80544 1/18/2018 79605 1/23/2018 70570 1/24/2018 81269 2/14/2018 60229 5/18/2014 61713 8/5/2014 62412 10/12/2014 62622 12/4/2014 63424 12/3/2014 63758 1/18/2015 64012 12/11/2014 66920 2/21/2015 67462 4/4/2015 68759 4/5/2015 69468 9/28/2015 70973 11/20/2015 72097 12/24/2015 73763 3/9/2016 74313 4/25/2016 75999 5/24/2016 77194 11/30/2016 79795 2/26/2017

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.

More recalls from Windstone Medical Packaging

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5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
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