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Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311...

FDA Device Recall #Z-0204-2017 — Class II — April 22, 2015

Recall Summary

Recall Number Z-0204-2017
Classification Class II — Moderate risk
Date Initiated April 22, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Windstone Medical Packaging, Inc.
Location Billings, MT
Product Type Devices
Quantity 8132 kits

Product Description

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room

Reason for Recall

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Distribution Pattern

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Lot / Code Information

Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328 12/13/2014 64679 12/18/2014 63368 12/20/2014 63799 1/13/2015 66644 2/2/2015 66509 2/14/2015 65777 2/25/2015 65573 2/25/2015 65718 2/28/2015 65875 3/6/2015 65572 3/15/2015 59027 3/26/2015 58692 4/5/2015 68613 4/12/2015 67175 4/14/2015 57249 4/20/2015 68069 4/28/2015 59297 7/3/2015 59538 7/4/2015 59157 7/13/2015 59846 8/2/2015 60663 8/4/2015 60131 8/5/2015 60113 8/6/2015 60132 8/6/2015 70171 8/13/2015 61311 8/18/2015 61435 8/20/2015 59514 8/24/2015 59845 8/31/2015 60605 9/7/2015 60754 9/7/2015 61006 9/7/2015 60722 9/11/2015 61164 9/14/2015 60662 9/20/2015 61479 9/21/2015 68892 9/29/2015 61310 10/16/2015 65295 11/2/2015 71133 11/2/2015 62199 11/5/2015 62600 11/5/2015 62349 11/6/2015 61601 11/6/2015 64476 11/6/2015 66318 11/6/2015 61521 11/7/2015 66319 11/8/2015 65296 11/10/2015 64850 11/11/2015 64477 11/11/2015 62200 11/13/2015 62943 11/13/2015 70754 11/13/2015 62903 11/14/2015 63199 11/15/2015 61602 11/23/2015 61642 11/26/2015 62425 11/27/2015 62546 11/27/2015 66795 11/27/2015 61603 11/29/2015 65598 11/30/2015 65700 11/30/2015 72347 12/4/2015 72783 12/15/2015 72804 12/21/2015 65699 12/23/2015 65294 12/26/2015 65195 12/27/2015 64632 1/2/2016 73047 1/6/2016 64291 1/7/2016 64349 1/8/2016 63430 1/9/2016 65019 1/12/2016 64475 1/16/2016 63200 1/18/2016 63711 1/22/2016 63948 1/25/2016 64042 1/30/2016 63984 1/30/2016 67589 2/5/2016 69258 2/5/2016 69459 2/5/2016 71210 2/11/2016 66794 2/14/2016 68862 2/14/2016 69603 2/20/2016 69604 2/20/2016 67588 2/24/2016 74530 2/25/2016 73860 3/6/2016 74555 3/10/2016 68572 3/13/2016 68863 3/22/2016 69062 3/26/2016 66552 4/4/2016 70511 4/6/2016 71878 4/8/2016 70512 4/10/2016 70267 4/14/2016 70268 4/16/2016 74731 4/18/2016 69605 4/20/2016 69866 4/23/2016 70510 4/24/2016 73286 4/24/2016 74443 4/25/2016 77115 5/10/2016 75128 5/17/2016 75800 5/22/2016 56502 5/23/2016 56722 5/30/2016 57013 6/7/2016 56723 6/12/2016 57469 6/18/2016 57573 6/27/2016 71877 7/2/2016 71435 7/4/2016 66796 7/5/2016 57790 7/8/2016 57774 7/9/2016 71073 7/13/2016 66551 7/14/2016 71879 7/15/2016 58288 7/16/2016 57645 7/17/2016 77366 7/17/2016 57945 7/18/2016 71437 7/18/2016 71982 7/22/2016 69061 7/26/2016 71268 7/26/2016 71981 7/29/2016 78379 7/29/2016 77328 7/30/2016 78043 7/30/2016 78160 7/30/2016 58451 7/31/2016 58067 8/2/2016 71436 8/5/2016 67206 8/11/2016 58275 8/14/2016 58587 8/30/2016 78339 8/31/2016 75047 9/2/2016 79834 10/12/2016 81141 10/31/2016 78837 11/5/2016 80914 11/6/2016 60593 11/26/2016 77334 7/20/2017 76451 7/22/2017 77342 10/1/2017

Other Recalls from Windstone Medical Packaging, Inc.

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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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