Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Cont...
FDA Device Recall #Z-1849-2021 — Class II — April 8, 2021
Recall Summary
| Recall Number | Z-1849-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Windstone Medical Packaging, Inc. |
| Location | Billings, MT |
| Product Type | Devices |
| Quantity | 190 units |
Product Description
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3
Reason for Recall
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Distribution Pattern
US Nationwide distribution in the state of AZ.
Lot / Code Information
Lot Number 146305, 147637, 148389, and 148814
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
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.