Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(...
FDA Device Recall #Z-0147-2017 — Class II — April 22, 2015
Recall Summary
| Recall Number | Z-0147-2017 |
| 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 | 6381 kits |
Product Description
Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. 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 Numbers/Expiration Dates: 56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 58068 7/11/2016 58357 7/31/2016 58588 4/10/2015 59298 3/11/2015 59847 9/13/2015 60274 11/4/2015 60353 7/18/2015 60354 7/22/2015 60649 10/28/2015 60797 11/5/2015 61071 10/3/2015 61873 11/28/2015 62203 11/7/2015 62456 11/28/2015 62945 11/2/2015 63065 9/3/2015 63204 11/11/2015 63665 1/29/2016 64166 1/6/2016 64470 1/13/2016 64559 1/29/2016 64750 1/18/2016 64819 10/11/2015 64976 1/14/2016 65020 6/27/2017 65048 11/1/2015 65116 1/17/2016 65411 11/1/2015 65442 11/15/2015 65737 2/15/2016 65804 2/25/2015 65879 12/22/2015 66321 11/12/2015 66395 6/27/2015 66696 11/4/2015 67207 11/16/2015 67521 8/21/2015 67551 7/23/2016 67694 5/2/2015 67700 7/26/2016 67701 7/4/2016 67810 8/10/2016 67966 7/15/2016 68145 8/28/2016 68387 7/6/2016 68410 9/21/2016 68413 9/25/2015 68710 9/13/2016 68711 9/22/2016 68721 9/18/2016 68822 9/5/2016 68857 2/21/2015 69056 11/26/2017 69067 9/20/2016 69191 9/16/2016 69343 9/5/2016 69344 9/11/2016 69345 9/14/2016 69549 9/20/2016 69646 12/24/2016 69893 3/29/2017 70157 9/12/2016 70176 12/12/2015 70966 7/11/2016 70970 10/10/2016 71156 12/27/2016 71450 2/13/2015 71634 1/5/2017 71634 1/5/2017 71788 10/20/2016 71945 1/3/2017 71955 2/7/2015 71987 1/21/2017 72112 3/24/2017 72306 1/7/2017 72490 3/21/2017 72616 3/23/2017 72640 3/12/2017 72978 3/1/2017 72978 3/1/2017 73191 8/21/2016 73203 3/8/2017 73204 4/20/2017 73428 4/4/2017 73645 1/22/2017 73646 4/5/2017 73826 7/27/2017 73933 4/13/2017 73933 4/13/2017 73934 5/3/2017 74061 1/16/2017 74442 4/20/2017 74460 5/9/2017 75094 5/4/2017 75255 6/21/2017 75455 6/25/2016 75646 7/16/2017 75745 6/27/2016 75830 7/9/2017 75902 7/11/2017 76026 7/2/2017 76034 7/23/2017 76083 4/23/2017 76141 7/9/2017 76142 4/23/2017 76152 7/30/2016 76161 8/30/2017 76236 7/15/2016 76662 10/25/2017 76680 8/29/2017 76917 8/5/2017 76948 8/30/2017 77315 10/1/2017 77434 8/14/2017 77518 9/27/2017 77771 10/9/2017 77845 8/23/2017 78027 9/2/2017 78325 8/26/2017 78337 11/9/2017 78641 9/2/2017 78743 9/19/2017 78879 11/2/2017 78980 1/6/2018 79248 9/10/2017 79315 1/17/2018 79497 1/2/2018 79657 2/2/2018 80442 2/26/2018 80608 1/19/2018 80916 1/9/2018
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.