HUDSON RCI IPN044067Recalls & reported problems
Teleflex Incorporated · COMFORT FLO® Nasal Cannula · Class 1
All models of HUDSON RCI (152)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704597468), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
COMPLAINT FROM MAUDE DATABASE: NARRATIVE FROM STAFF: INFANT'S NASAL CANNULA PRONGS FOUND DURING MORNING ROUTINE HANDS ON CARE WITH ONE SIDE OF THE TUBING DISCONNECTED/BROKEN AT HUB. INFANT NOT RECEIVING FULL AMOUNT OF AIR FLOW AS ORDERED. UNKNOWN WHEN DISCONNECTION HAPPENED. MANUFACTURER RESPONSE FOR HUDSON RCI COMFORT FLO NASAL CANNULA. PREMATURE., COMFORT FLO NASAL CANNULA (PER SITE REPORTER): MANUFACTURER REPRESENTATIVE IS WORKING ON GATHERING INFORMATION AND DEVICE WILL BE PROVIDED TO HIM ONCE A SHIPPER KIT IS SENT TO US.
Patient problems: Low Oxygen Saturation
MAUDE report 12315441 ↗
Other CANNULA, NASAL, OXYGEN devices
- Fisher & Paykel Healthcare OPT844Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen39 reports
- Fisher and Paykel Healthcare OPT312Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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