Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product ...
FDA Device Recall #Z-1403-2018 — Class II — March 27, 2018
Recall Summary
| Recall Number | Z-1403-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 27, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Teleflex Medical Europe Ltd |
| Location | Athlone |
| Product Type | Devices |
| Quantity | 103910 units |
Product Description
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Reason for Recall
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Distribution Pattern
US Nationwide in the states of AU, CA, NZ
Lot / Code Information
Lot Numbers: 74D1501706 74K1502092 74F1600367 74J1600117 74L1601916 74C1701733 74F1700707 74D1501731 74K1502045 74F1601072 74J1601101 74M1600284 74C1702365 74F1701866 74G1500664 74M1501145 74F1601874 74J1601563 74M1601685 74D1700030 74F1702612 74G1500663 74A1601936 74F1602470 74J1602238 74A1700107 74D1700363 74G1700034 74G1502412 74B1600334 74G1600466 74K1600148 74A1701335 74D1701038 74G1700488 74H1500466 74C1600162 74H1600217 74K1600287 74A1701403 74D1701507 74G1701144 74H1500189 74D1601420 74H1600516 74K1601020 74A1702060 74E1700450 74G1702002 74H1501260 74D1601965 74H1601371 74K1601924 74A1702874 74E1700965 74H1700127 74H1501971 74E1600800 74H1601372 74L1600063 74B1701032 74E1701630 74H1700791 74J1501554 74E1601571 74H1602060 74L1600278 74B1700172 74E1702399 74H1701752 74K1500354 74E1600116 74H1602061 74L1601099 74C1700868 74F1700125 74H1702374
Other Recalls from Teleflex Medical Europe Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2319-2021 | Class II | RUSCH Slick Set Cuffed Endotracheal Tube and St... | Jul 16, 2021 |
| Z-2322-2021 | Class II | RUSCH Endotracheal Tube oral/nasal Murphy Eye, ... | Jul 16, 2021 |
| Z-2321-2021 | Class II | RUSCH Endotracheal Tube oral/nasal Magill, High... | Jul 16, 2021 |
| Z-2320-2021 | Class II | RUSCH Flexi-Set Cuffed Endotracheal Tube and St... | Jul 16, 2021 |
| Z-2287-2018 | Class II | Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 ... | Jun 12, 2018 |
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.