FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAroun...
FDA Device Recall #Z-1059-2023 — Class III — January 3, 2023
Recall Summary
| Recall Number | Z-1059-2023 |
| Classification | Class III — Low risk |
| Date Initiated | January 3, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Owens & Minor Distribution, Inc. |
| Location | Mechanicsville, VA |
| Product Type | Devices |
| Quantity | 73 cases |
Product Description
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Reason for Recall
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
Distribution Pattern
US distribution to IL, NC, NY, OH, and PA.
Lot / Code Information
UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Other Recalls from Owens & Minor Distribution, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0343-2023 | Class II | Aero Blue Performance Surgical Gown, XL- Steril... | Oct 31, 2022 |
| Z-0888-2017 | Class II | Medi Choice Arm Slings ASL 2103 Small 7.5 x ... | Oct 31, 2016 |
| Z-0734-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of c... | Nov 17, 2015 |
| Z-0733-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of c... | Nov 17, 2015 |
| Z-0735-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of c... | Nov 17, 2015 |
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.