HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
FDA Device Recall #Z-1112-2020 — Class I — December 13, 2019
Recall Summary
| Recall Number | Z-1112-2020 |
| 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 | 30566 devices |
Product Description
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, 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 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071
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.