McKesson 16-0538Recalls & reported problems
Mckesson Medical-Surgical Inc. · CO2 Sampling Nasal Cannula ADULT, 10’ (3 m) O2/CO2 SAMPLING LINE WITH MALE LUER SINGLE PATIENT USE · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612479208605), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Obstruction of Flow; Obstruction of Flow
WHILE NO HARM OR INJURY WAS REPORTED, THE AIR IS NOT PASSING THROUGH THE CANNULA, DURING PATIENT USE, COULD RESULT IN A DELAY IN THERAPY, AND OR A LACK OF OXYGEN DELIVERY TO THE PATIENT WHICH COULD RESULT IN SERIOUS HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433212 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.