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Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part nu...

FDA Device Recall #Z-1295-2017 — Class II — January 11, 2017

Recall Summary

Recall Number Z-1295-2017
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 810 kits

Product Description

Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A

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 100226, 9/11/2019 101400, 10/7/2019 84373, 5/28/2018 84678, 6/8/2018 84896, 5/26/2018 84959, 7/29/2018 85470, 2/23/2017 85505, 7/23/2018 85547, 8/23/2018 85695, 7/8/2018 85846, 8/5/2018 86258, 9/19/2018 86509, 9/28/2018 86663, 8/11/2019 86686, 9/9/2018 86908, 9/13/2018 87155, 9/16/2018 87730, 7/5/2017 87968, 9/6/2018 88008, 7/1/2017 88862, 2/7/2018 89394, 11/15/2017 89546, 7/21/2017 89832, 12/29/2018 95313, 9/16/2019 95453, 1/22/2019 95880, 6/12/2019 96000, 1/6/2019 96383, 5/25/2018 96384, 5/13/2018 96923, 5/1/2019 97709, 5/1/2019 99376, 6/7/2019

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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