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Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AM...

FDA Device Recall #Z-1284-2017 — Class II — January 11, 2017

Recall Summary

Recall Number Z-1284-2017
Classification Class II — Moderate risk
Date Initiated January 11, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Windstone Medical Packaging, Inc.
Location Billings, MT
Product Type Devices
Quantity 4155 kits

Product Description

Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463

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.

Distribution Pattern

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.

Lot / Code Information

Lot number and expiration date 100084, 10/2/2019 100678, 10/22/2019 100683, 10/13/2019 100700, 9/5/2019 100771, 7/9/2019 100772, 7/23/2019 101188, 9/6/2019 101555, 9/9/2019 84253, 5/12/2018 84254, 5/25/2018 84377, 9/10/2018 84493, 5/28/2018 84494, 5/28/2018 84495, 6/22/2018 84681, 7/22/2018 84682, 7/29/2018 84853, 7/22/2018 84919, 6/3/2018 86006, 8/22/2018 86135, 9/29/2018 86853, 10/31/2018 87162, 8/10/2019 87171, 8/20/2018 87229, 10/5/2018 87582, 12/28/2018 87615, 12/17/2018 88006, 9/23/2018 88227, 9/5/2018 88559, 11/14/2018 88573, 11/12/2018 88574, 11/14/2018 88692, 2/28/2018 88693, 12/9/2018 88899, 11/24/2018 89221, 12/7/2018 89554, 12/9/2018 89555, 1/6/2019 89762, 1/10/2019 94731, 11/12/2018 95058, 1/18/2019 95061, 1/13/2019 95477, 12/7/2018 95510, 1/25/2019 95631, 3/7/2019 95654, 1/10/2019 95874, 6/27/2019 96054, 1/13/2019 96361, 3/10/2019 96458, 1/25/2019 96477, 1/25/2019 96478, 6/23/2019 96834, 6/10/2019 96988,6/9/2019 97000, 6/29/2019 97166, 5/11/2019 97547, 5/7/2019 97820, 6/7/2019 98230, 6/8/2019 98588, 6/7/2019 98753, 6/3/2019 99515, 9/21/2019 99516, 9/30/2019 99564, 9/8/2019 99603, 10/4/2019

Other Recalls from Windstone Medical Packaging, Inc.

Recall # Classification Product Date
Z-0031-2025 Class II Aligned Medical Tonsil Pack REF AMS14809 that c... Aug 16, 2024
Z-0030-2025 Class II Aligned Medical T and A Pack REF AMS11482 that ... Aug 16, 2024
Z-0027-2025 Class II Aligned Medical Tonsil Tray REF AMS9300A that c... Aug 16, 2024
Z-0028-2025 Class II Aligned Medical Tonsil ENT Pack REF AMS9977 tha... Aug 16, 2024
Z-0029-2025 Class II Aligned Medical Septo Pack REF AMS11480 that co... Aug 16, 2024

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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