CLASS II Device recall · Reported 8 Mar 2017 · FDA Enforcement Report
Shoulder Pack recalled by Windstone Medical Packaging
Windstone Medical Packaging is recalling Shoulder 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
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-1369-2017
- 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
Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A
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.
ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNebraskaNew JerseyNevada
Questions about this recall
Is Shoulder Pack recalled?
Yes. Windstone Medical Packaging recalled Shoulder Pack on 11 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1369-2017.
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 100412, 8/14/2018 100837, 10/19/2019 101181, 10/9/2019 83278, 5/27/2018 83634, 5/20/2017 84945, 6/24/2017 85147, 7/28/2017 85150, 7/15/2018 85258, 6/10/2018 85541, 7/14/2018 85554, 7/2/2018 85555, 7/7/2018 86259, 7/2/2017 86308, 9/20/2018 86488, 10/29/2018 86512, 9/28/2018 86688, 11/16/2019 86747, 8/3/2018 87122, 10/7/2017 87798, 10/28/2017 88399, 10/19/2017 88404, 11/20/2018 89040, 12/14/2017 89088, 12/10/2018 89598, 11/18/2018 89887, 12/16/2018 95111, 12/12/2017 95287, 6/15/2019 95811, 2/23/2018 96607, 1/7/2018 97133, 2/7/2018 97290, 5/22/2019 98325, 3/26/2018 98687, 6/14/2019 99065, 6/13/2018 99548, 9/27/2019
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.
More recalls from Windstone Medical Packaging
All 336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
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All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |