CARDINAL HEALTH ZRCN01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885380116196), received between Jan 15, 2019 and Jan 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031413); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2019Device Emits Odor

  GOT FIRST NEBULIZER MACHINE ON (B)(6) 2018 CALLED (B)(6) PHARMACY ON (B)(6) 2018, WAS TOLD BY THEM TO RETURN IT. THE NEBULIZER WAS RETURNED BECAUSE IT HAD STRONG CHEMICAL SMELL COMING FROM THE MACHINE (WITHOUT THE HOSE HOOKED TO IT). COULD TASTE THE CHEMICAL IN MY MOUTH. I USED THE 2ND MACHINE ONLY 2 DAYS BECAUSE IT TOO HAD A STRONG CHEMICAL TASTE AND SMELL COMING FROM IT ALSO. WAS TOLD BY (B)(6) PHARMACY BEFORE I RETURN THE 2ND MACHINE, I HAD TO CALL CARDINAL HEALTH AND GET THE OK FROM THEM. CARDINAL HEALTH SAID IT WAS OK TO RETURN THE 2ND MACHINE TO (B)(6) PHARMACY SO I DID ON (B)(6) 2018. I GOT A REPLACEMENT NEBULIZER MACHINE FOR A DIFFERENT MFR(PHILIPS) AND THERE WAS NO CHEMICAL SMELL OR TASTE FROM IT. CARDINAL HEALTH.

  Patient problems: Chemical Exposure

  MAUDE report 8254019 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031413. One submission often covers many models, so check the product and lot details in each record.

• Z-1720-2015 · Apr 20, 2015 · Terminated
  Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.