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

Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771 recalled

Windstone Medical Packaging is recalling Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, 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: 60238 4/27/2014 63592 5/22/2014 61110 5/31/2014 64981 6/6/2014 64360 6/6/2014 63344 6/17/2014 62792 6/18/2014 63990 6/23/2014 61099 8/21/2014 59122 9/20/2014 65818 11/18/2014 72314 11/25/2014 57135 1/21/2015 65766 2/26/2015 73492 3/31/2015 59151 4/24/2015 57576 5/8/2015 70776 5/13/2015 58841 5/15/2015 57136 5/25/2015 59700 7/8/2015 60764 8/7/2015 61177 8/12/2015 61496 8/15/2015 59482 8/19/2015 60670 9/12/2015 60618 9/15/2015 60619 9/20/2015 61098 9/27/2015 65575 10/17/2015 65113 10/18/2015 60828 10/27/2015 62788 11/2/2015 61930 11/4/2015 61354 11/6/2015 66242 11/7/2015 65407 11/8/2015 62515 11/10/2015 65328 11/10/2015 65380 11/16/2015 62064 11/18/2015 61734 11/22/2015 63294 11/28/2015 63296 11/28/2015 63350 12/9/2015 63743 12/11/2015 62511 12/25/2015 63037 12/25/2015 63371 12/28/2015 63295 12/28/2015 64672 1/13/2016 63423 1/16/2016 63746 1/22/2016 63751 1/23/2016 61978 1/28/2016 75438 5/18/2016 57063 5/22/2016 71254 5/26/2016 56759 5/31/2016 57500 6/20/2016 75530 6/25/2016 56878 7/5/2016 67109 7/5/2016 68691 7/7/2016 66642 7/11/2016 57583 7/12/2016 67283 7/19/2016 57518 7/21/2016 67771 7/29/2016 68690 7/30/2016 58316 8/13/2016 58533 8/16/2016 58916 8/23/2016 58970 8/23/2016 68245 9/3/2016 69838 9/15/2016 69469 9/20/2016 66608 9/21/2016 70428 9/29/2016 70203 10/21/2016 69728 11/2/2016 68983 11/16/2016 70998 12/17/2016 71524 12/17/2016 72094 12/18/2016 72507 1/10/2017 72343 1/15/2017 70557 1/17/2017 72354 1/20/2017 72864 1/21/2017 73491 1/22/2017 73575 1/27/2017 72972 3/5/2017 73284 3/7/2017 72863 3/15/2017 73094 3/24/2017 72768 3/29/2017 73764 4/18/2017 74120 4/19/2017 73432 5/21/2017 74424 5/22/2017 74838 5/23/2017 76477 7/20/2017 75810 7/22/2017 75363 7/23/2017 74113 7/27/2017 75811 7/28/2017 75818 7/29/2017 78094 8/29/2017 77196 8/30/2017 77752 9/2/2017 78208 9/15/2017 77605 9/19/2017 76282 9/30/2017 77372 10/8/2017 76910 10/24/2017 78629 11/3/2017 78209 11/3/2017 78766 11/9/2017 79083 11/24/2017 78611 1/4/2018 78612 1/9/2018 78115 1/11/2018 79596 1/24/2018 79230 2/1/2018 79229 2/19/2018 79812 2/28/2018

Quantity recalled6526 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-0165-2017
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

Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. 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 Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207 recalled?

Yes. Windstone Medical Packaging recalled Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207 on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0165-2017.

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: 60238 4/27/2014 63592 5/22/2014 61110 5/31/2014 64981 6/6/2014 64360 6/6/2014 63344 6/17/2014 62792 6/18/2014 63990 6/23/2014 61099 8/21/2014 59122 9/20/2014 65818 11/18/2014 72314 11/25/2014 57135 1/21/2015 65766 2/26/2015 73492 3/31/2015 59151 4/24/2015 57576 5/8/2015 70776 5/13/2015 58841 5/15/2015 57136 5/25/2015 59700 7/8/2015 60764 8/7/2015 61177 8/12/2015 61496 8/15/2015 59482 8/19/2015 60670 9/12/2015 60618 9/15/2015 60619 9/20/2015 61098 9/27/2015 65575 10/17/2015 65113 10/18/2015 60828 10/27/2015 62788 11/2/2015 61930 11/4/2015 61354 11/6/2015 66242 11/7/2015 65407 11/8/2015 62515 11/10/2015 65328 11/10/2015 65380 11/16/2015 62064 11/18/2015 61734 11/22/2015 63294 11/28/2015 63296 11/28/2015 63350 12/9/2015 63743 12/11/2015 62511 12/25/2015 63037 12/25/2015 63371 12/28/2015 63295 12/28/2015 64672 1/13/2016 63423 1/16/2016 63746 1/22/2016 63751 1/23/2016 61978 1/28/2016 75438 5/18/2016 57063 5/22/2016 71254 5/26/2016 56759 5/31/2016 57500 6/20/2016 75530 6/25/2016 56878 7/5/2016 67109 7/5/2016 68691 7/7/2016 66642 7/11/2016 57583 7/12/2016 67283 7/19/2016 57518 7/21/2016 67771 7/29/2016 68690 7/30/2016 58316 8/13/2016 58533 8/16/2016 58916 8/23/2016 58970 8/23/2016 68245 9/3/2016 69838 9/15/2016 69469 9/20/2016 66608 9/21/2016 70428 9/29/2016 70203 10/21/2016 69728 11/2/2016 68983 11/16/2016 70998 12/17/2016 71524 12/17/2016 72094 12/18/2016 72507 1/10/2017 72343 1/15/2017 70557 1/17/2017 72354 1/20/2017 72864 1/21/2017 73491 1/22/2017 73575 1/27/2017 72972 3/5/2017 73284 3/7/2017 72863 3/15/2017 73094 3/24/2017 72768 3/29/2017 73764 4/18/2017 74120 4/19/2017 73432 5/21/2017 74424 5/22/2017 74838 5/23/2017 76477 7/20/2017 75810 7/22/2017 75363 7/23/2017 74113 7/27/2017 75811 7/28/2017 75818 7/29/2017 78094 8/29/2017 77196 8/30/2017 77752 9/2/2017 78208 9/15/2017 77605 9/19/2017 76282 9/30/2017 77372 10/8/2017 76910 10/24/2017 78629 11/3/2017 78209 11/3/2017 78766 11/9/2017 79083 11/24/2017 78611 1/4/2018 78612 1/9/2018 78115 1/11/2018 79596 1/24/2018 79230 2/1/2018 79229 2/19/2018 79812 2/28/2018

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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