Parker H-PFNC-65Recalls & reported problems

Salter Labs · Endotracheal Tube, Preformed Nasal, High Volume Low Pressure, Cuffed (PFNC), Parker, 6.5mm Parker Original DID: 10749065031655. · Class 2

All models of Parker (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411954429), received between Jul 3, 2025 and Oct 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Integrity Problem3

Patient problems

Skin Inflammation/ Irritation3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 29, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING INTUBATION, THERE WAS RESISTANCE. UPON EXAMINATION WITH A VIDEO LARYNGOSCOPE, BLEEDING WAS OBSERVED. IT APPEARED DIFFICULT TO PASS THE ENDOSCOPE THROUGH THE POSTERIOR PHARYNGEAL WALL, WHICH RESULTED IN MUCOSAL DAMAGE THE TUBE WAS REMOVED, AND ORAL INTUBATION WAS PERFORMED. THIS INCIDENT CAUSED A DELAY IN INTUBATION, PATIENT THERAPY, AND HARM TO THE PATIENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23419260 ↗
MalfunctionJul 3, 2025Material Integrity Problem; Material Integrity Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3004748541-2025-00023 FOR THE FIRST REPORT REFER TO 3004748541-2025-00024 FOR THE SECOND REPORT . REFER TO . FOR THE THIRD REPORT . IT WAS REPORTED, A NOSEBLEED OCCURRED IMMEDIATELY AFTER THE START OF USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 22401209 ↗
MalfunctionJul 3, 2025Material Integrity Problem; Material Integrity Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3004748541-2025-00024 FOR THE SECOND REPORT REFER TO 3004748541-2025-00025 FOR THE THIRD REPORT . IT WAS REPORTED, A NOSEBLEED OCCURRED IMMEDIATELY AFTER THE START OF USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 22401208 ↗

Device details

UDI-DI	`00607411954429`
Brand	Parker
Model	H-PFNC-65
Company	Salter Labs
Product code	BTR · Tube, Tracheal (W/Wo Connector)
Class	Class 2
FDA submission	K100546
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 19, 2020

Device type (GMDN): Basic endotracheal tube, single-use

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

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All Tube, Tracheal (W/Wo Connector) devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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