CLASS II Device recall · Reported 8 Mar 2017 · FDA Enforcement Report

Open Procedure Pack recalled by Windstone Medical Packaging

Windstone Medical Packaging is recalling Open Procedure Pack, distributed in 26 states. The recall was initiated on 11 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number and expiration date 100206, 6/1/2018 100248, 7/9/2018 100438, 7/19/2018 100439, 8/29/2018 100853, 9/15/2018 86832, 10/10/2017 88268, 10/4/2017 89377 ,11/9/2017 89378, 12/9/2017 94967, 12/31/2017 95888, 1/5/2018 96199, 2/11/2018 97018, 1/9/2018 97019, 2/17/2018 97146, 4/28/2018 97301, 3/22/2018 97478, 6/13/2018 98189, 5/20/2018

Quantity recalled1125 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-1350-2017
FDA event ID: 76280
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2017
FDA classified: 28 Feb 2017
Reported: 8 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

11 Jan 2017	Recall initiated by company
28 Feb 2017	Classified by FDA	+48 days
8 Mar 2017	Published in enforcement report	+8 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 of the custom Aligned Medical Solutions (AMS) kits 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

Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B

Where it was distributed

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina North Dakota Nebraska New Jersey Nevada

Questions about this recall

Is Open Procedure Pack recalled?

Yes. Windstone Medical Packaging recalled Open Procedure Pack on 11 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1350-2017.

Why was it recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Which lots are affected?

Lot number and expiration date 100206, 6/1/2018 100248, 7/9/2018 100438, 7/19/2018 100439, 8/29/2018 100853, 9/15/2018 86832, 10/10/2017 88268, 10/4/2017 89377 ,11/9/2017 89378, 12/9/2017 94967, 12/31/2017 95888, 1/5/2018 96199, 2/11/2018 97018, 1/9/2018 97019, 2/17/2018 97146, 4/28/2018 97301, 3/22/2018 97478, 6/13/2018 98189, 5/20/2018

Where was it sold?

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

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

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