CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Teleflex Medical Hudson Rci One Way Valve w recalled
Teleflex Medical Europe is recalling Teleflex Medical Hudson Rci One Way Valve w, distributed nationwide in the US. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1403-2018
- FDA event ID
- 79670
- Recalling firm
- Teleflex Medical Europe, Athlone
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Mar 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 27 Mar 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +21 days |
| 25 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide in the states of AU, CA, NZ
Questions about this recall
Is Teleflex Medical Hudson Rci One Way Valve w recalled?
Yes. Teleflex Medical Europe recalled Teleflex Medical Hudson Rci One Way Valve w on 27 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1403-2018.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide in the states of AU, CA, NZ
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |