McKesson 16-C60PRecalls & reported problems

Mckesson Medical-Surgical Inc. · Anesthesia Circuits COAXIAL 60" Pediatric · Class 2

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 10612479210797), received between Mar 24, 2023 and Mar 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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.

Most reported problems

Device problems

Partial Blockage1

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.

MalfunctionMar 24, 2023Partial Blockage; Partial Blockage
DISTAL END OF THE COAXIAL CIRCUIT HAD AN OBSTRUCTION IN THE INTERNAL (INSPIRATORY) LIMB AND WHEN THE OUTER LIMB WAS CUT OPEN, THE INTERNAL LIMB WAS FOUND TO BE TWISTED AND GREATER THAN 75% OCCLUDED. THE PATIENT DID HAVE A PROLONGED INDUCTION OF ANESTHESIA WITH OBSTRUCTED ATTEMPT TO INSPIRE AND REQUIRED IM KETAMINE THAT PROLONGED HIS RETURN TO FULL ALERTNESS AND RECOVERY FROM ANESTHESIA. WHILE THE PATIENT HAD NO HYPOXEMIA OR LONG TERM SEQUELAE DUE TO EARLY RECOGNITION OF THE DEFECT BY EXPERIENCED PRACTITIONERS, THIS MANUFACTURING DEFECT COULD HAVE CAUSED PROFOUND HYPOXEMIA, INSPIRATORY OBSTRUCTION CAUSING POST OBSTRUCTIVE. PULMONARY EDEMA OR ANESTHESIA MACHINE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16612863 ↗

Device details

UDI-DI	`10612479210797`
Brand	McKesson
Model	16-C60P
Company	Mckesson Medical-Surgical Inc.
Product code	CAH · Filter, Bacterial, Breathing-Circuit
Class	Class 2
FDA submission	K922492
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 22, 2020

Device type (GMDN): Microbial medical gas filter, single-use

A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.