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Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A ...

FDA Device Recall #Z-1276-2017 — Class II — January 11, 2017

Recall Summary

Recall Number Z-1276-2017
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 1436 kits

Product Description

Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430

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 100634, 9/23/2018 83241, 6/20/2017 83757, 6/1/2017 84174, 1/14/2017 84249, 1/20/2017 84496, 6/21/2017 84521, 3/19/2017 84904, 4/28/2017 84910, 1/25/2017 85071, 11/30/2017 85126, 6/28/2017 85126, 6/28/2017 85162, 1/17/2017 85565, 1/24/2017 85634, 6/11/2017 85820, 3/25/2017 85831, 6/14/2017 85985, 7/15/2017 86062, 4/21/2017 86141, 3/19/2017 86656, 7/10/2017 86797, 2/5/2018 86862, 6/18/2017 87093, 6/26/2017 87110, 8/22/2017 87747, 3/21/2017 88532, 2/11/2018 89014, 9/9/2017 89155, 12/22/2017 89244, 12/13/2017 89569, 12/3/2017 89770, 5/3/2017 89932, 7/7/2017 94601, 5/16/2017 95184, 7/29/2017 95185, 5/12/2017 95224, 5/1/2017 95265, 3/20/2018 95623, 9/22/2017 95793, 12/1/2017 96299, 5/22/2019 96563, 3/28/2018 96987, 5/21/2017 97563, 12/22/2017 97564, 3/30/2018 97902, 2/9/2018 98436, 3/7/2018 98445, 12/25/2018 98900, 2/28/2018 98937, 9/12/2018 98980, 2/3/2018 99258, 3/8/2018

Other Recalls from Windstone Medical Packaging, Inc.

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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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