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

Set-Up Pack, Kit number PSS1305(B recalled

Windstone Medical Packaging is recalling Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general, 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 Number/ Expiration Date: 67723 11/19/2015 61928 11/20/2015 56692 7/19/2016 67757 7/22/2016 58305 8/6/2016 58345 8/14/2016 69798 9/14/2016 69922 9/16/2016 69923 9/29/2016 58346 10/4/2016 70578 10/11/2016 68747 10/12/2016 69280 10/23/2016 70579 12/5/2016 70580 12/26/2016 70988 3/23/2017 73558 4/24/2017 74320 5/24/2017 74472 5/25/2017 75989 7/16/2017 77190 7/21/2017 76466 7/22/2017 74850 7/23/2017 76890 7/23/2017 75368 7/30/2017 76891 8/4/2017 76903 8/10/2017 77517 8/29/2017 77987 9/5/2017 77361 10/10/2017 78110 1/9/2018 78111 2/6/2018

Quantity recalled2225 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-0268-2017
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

Set-Up Pack, Kit number PSS1305(B and PSS1305(C 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 Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general recalled?

Yes. Windstone Medical Packaging recalled Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0268-2017.

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 Number/ Expiration Date: 67723 11/19/2015 61928 11/20/2015 56692 7/19/2016 67757 7/22/2016 58305 8/6/2016 58345 8/14/2016 69798 9/14/2016 69922 9/16/2016 69923 9/29/2016 58346 10/4/2016 70578 10/11/2016 68747 10/12/2016 69280 10/23/2016 70579 12/5/2016 70580 12/26/2016 70988 3/23/2017 73558 4/24/2017 74320 5/24/2017 74472 5/25/2017 75989 7/16/2017 77190 7/21/2017 76466 7/22/2017 74850 7/23/2017 76890 7/23/2017 75368 7/30/2017 76891 8/4/2017 76903 8/10/2017 77517 8/29/2017 77987 9/5/2017 77361 10/10/2017 78110 1/9/2018 78111 2/6/2018

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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