HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
FDA Device Recall #Z-1114-2020 — Class I — December 13, 2019
Recall Summary
| Recall Number | Z-1114-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | December 13, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TELEFLEX MEDICAL INC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 127293 devices |
Product Description
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
Reason for Recall
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Distribution Pattern
nationwide
Lot / Code Information
GTIN 14026704659347 Lot Numbers: 74M1400306 74M1400711 74M1401528 74B1500017 74C1501165 74C1502056 74D1500014 74D1500695 74D1501704 74D1501219 74D1501910 74E1500306 74E1501372 74E1501373 74E1501374 74E1501375 74E1501371 74M1500846 74M1501089 74A1600595 74A1601230 74B1600045 74C1601038 74C1601644 74C1602406 74C1601594 74C1602113 74C1602114 74C1602115 74C1602116 74C1602117 74C1602146 74D1600254 74D1600253 74D1601801 74E1600052 74E1601253 74F1600669 74F1603321 74G1600071 74G1601038 74H1600051 74H1600052 74H1603043 74J1601205 74J1601478 74J1602063 74J1602658 74J1602865 74J1602864 74K1602260 74K1602874 74L1600133 74L1601767 74L1602602 74M1600527 74M1601523 74A1700288 74A1700995 74A1701895 74B1701971 74B1702316 74C1701847 74D1700109 74D1701791 74E1700933 74E1702182 74E1702251 74F1700030 74F1702959 74G1700802 74H1700006 74H1700404 74J1700408 74J1701883 74J1701884 74K1700025 74K1700305 74L1700955 74L1701845 74M1700483 74A1801553 74B1801391 74C1802117 74C1802118 74D1800085 74D1801077 74E1800628 74E1800789 74E1802236 74F1800042 74E1803151 74F1801157 74G1800356 74H1800881 74H1802700 74K1800753 74L1802033 74M1800649 74A1900149 74A1901354 74A1901414 74B1900011 74B1900245 74B1902467 74D1901101 74D1903025
Other Recalls from TELEFLEX MEDICAL INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1126-2022 | Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... | Apr 11, 2022 |
| Z-1127-2022 | Class II | (1) Teleflex Flex tube, Product #20011, sterile... | Apr 11, 2022 |
| Z-0628-2022 | Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0625-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0623-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
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.