HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier n...
FDA Device Recall #Z-1115-2020 — Class I — December 13, 2019
Recall Summary
| Recall Number | Z-1115-2020 |
| 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 | 95696 devices |
Product Description
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, 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 14026704659354 Lot Numbers: 74M1400307 74M1400712 74M1401529 74B1500058 74C1501166 74C1502785 74D1500015 74D1501870 74D1500696 74D1501220 74D1502153 74E1500307 74E1500858 74E1500862 74E1501080 74E1501081 74M1500348 74M1500349 74L1502756 74A1601231 74A1602020 74A1602926 74C1601469 74C1601958 74C1600012 74C1601957 74C1602147 74D1600255 74D1600256 74D1601787 74E1600053 74E1601254 74F1600670 74F1602336 74F1603322 74G1600072 74H1600054 74H1600053 74J1600489 74J1602064 74J1603174 74J1602868 74J1602870 74K1601772 74K1602259 74L1600134 74L1601768 74L1602603 74M1601671 74A1701896 74B1700016 74C1700027 74E1700001 74E1700934 74E1702183 74E1701545 74F1702944 74G1700799 74G1701641 74H1700405 74J1700025 74J1701885 74J1702647 74K1700429 74K1702509 74L1700956 74L1702261 74M1700484 74A1801554 74C1800450 74D1800086 74D1801078 74E1800788 74F1801158 74G1800976 74J1800380 74K1800754 74K1800571 74M1800650 74B1900012 74B1900643 74B1902468
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.