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

General Surgery Pack, Kit number PSS1380(A convenience recalled

Windstone Medical Packaging is recalling General Surgery Pack, Kit number PSS1380(A 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 Numbers/ Expiration Dates: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015 63873 1/24/2016 66910 5/30/2016 72335 7/8/2016 72751 7/25/2016 79224 9/10/2017 75804 10/9/2017 79488 1/9/2018

Quantity recalled168 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-0198-2017
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

General Surgery Pack, Kit number PSS1380(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 General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general recalled?

Yes. Windstone Medical Packaging recalled General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0198-2017.

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: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015 63873 1/24/2016 66910 5/30/2016 72335 7/8/2016 72751 7/25/2016 79224 9/10/2017 75804 10/9/2017 79488 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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