Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, P...
FDA Device Recall #Z-0165-2017 — Class II — April 22, 2015
Recall Summary
| Recall Number | Z-0165-2017 |
| 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 | 6526 kits |
Product Description
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. 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: 60238 4/27/2014 63592 5/22/2014 61110 5/31/2014 64981 6/6/2014 64360 6/6/2014 63344 6/17/2014 62792 6/18/2014 63990 6/23/2014 61099 8/21/2014 59122 9/20/2014 65818 11/18/2014 72314 11/25/2014 57135 1/21/2015 65766 2/26/2015 73492 3/31/2015 59151 4/24/2015 57576 5/8/2015 70776 5/13/2015 58841 5/15/2015 57136 5/25/2015 59700 7/8/2015 60764 8/7/2015 61177 8/12/2015 61496 8/15/2015 59482 8/19/2015 60670 9/12/2015 60618 9/15/2015 60619 9/20/2015 61098 9/27/2015 65575 10/17/2015 65113 10/18/2015 60828 10/27/2015 62788 11/2/2015 61930 11/4/2015 61354 11/6/2015 66242 11/7/2015 65407 11/8/2015 62515 11/10/2015 65328 11/10/2015 65380 11/16/2015 62064 11/18/2015 61734 11/22/2015 63294 11/28/2015 63296 11/28/2015 63350 12/9/2015 63743 12/11/2015 62511 12/25/2015 63037 12/25/2015 63371 12/28/2015 63295 12/28/2015 64672 1/13/2016 63423 1/16/2016 63746 1/22/2016 63751 1/23/2016 61978 1/28/2016 75438 5/18/2016 57063 5/22/2016 71254 5/26/2016 56759 5/31/2016 57500 6/20/2016 75530 6/25/2016 56878 7/5/2016 67109 7/5/2016 68691 7/7/2016 66642 7/11/2016 57583 7/12/2016 67283 7/19/2016 57518 7/21/2016 67771 7/29/2016 68690 7/30/2016 58316 8/13/2016 58533 8/16/2016 58916 8/23/2016 58970 8/23/2016 68245 9/3/2016 69838 9/15/2016 69469 9/20/2016 66608 9/21/2016 70428 9/29/2016 70203 10/21/2016 69728 11/2/2016 68983 11/16/2016 70998 12/17/2016 71524 12/17/2016 72094 12/18/2016 72507 1/10/2017 72343 1/15/2017 70557 1/17/2017 72354 1/20/2017 72864 1/21/2017 73491 1/22/2017 73575 1/27/2017 72972 3/5/2017 73284 3/7/2017 72863 3/15/2017 73094 3/24/2017 72768 3/29/2017 73764 4/18/2017 74120 4/19/2017 73432 5/21/2017 74424 5/22/2017 74838 5/23/2017 76477 7/20/2017 75810 7/22/2017 75363 7/23/2017 74113 7/27/2017 75811 7/28/2017 75818 7/29/2017 78094 8/29/2017 77196 8/30/2017 77752 9/2/2017 78208 9/15/2017 77605 9/19/2017 76282 9/30/2017 77372 10/8/2017 76910 10/24/2017 78629 11/3/2017 78209 11/3/2017 78766 11/9/2017 79083 11/24/2017 78611 1/4/2018 78612 1/9/2018 78115 1/11/2018 79596 1/24/2018 79230 2/1/2018 79229 2/19/2018 79812 2/28/2018
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.