Celerity LCB044Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10724995154230), received between Aug 31, 2022 and Aug 28, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1793-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS IN THE PROCESS OF ACTIVATING THE CELERITY 20 HP BIOLOGICAL INDICATOR AND OBSERVED "WHITE SPOTS" ON THEIR FINGERS. THE EMPLOYEE SOUGHT TREATMENT AND PLACED THEIR FINGERS IN WATER. THE EMPLOYEE WAS ALSO ADVISED TO APPLY OINTMENT (VASELINE).

  Patient problems: Skin Discoloration

  MAUDE report 17631820 ↗
• MalfunctionFeb 10, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5114138 THAT THERE WAS NO MEDIA IN THE CAP FOR BIOLOGICAL TESTING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358303 ↗
• MalfunctionOct 28, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A "BURN" AFTER HANDLING THEIR CELERITY 20 HP BIOLOGICAL INDICATOR. THE EMPLOYEE WASHED THEIR HANDS AND WENT TO THE ER.

  Patient problems: Burn(s)

  MAUDE report 15693195 ↗
• MalfunctionAug 31, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A "BURN" WHILE HANDLING THEIR BIOLOGICAL INDICATOR. THE EMPLOYEE SELF-TREATED BY RINSING THE BURN. IT IS UNKNOWN IF ADDITIONAL MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Burn(s)

  MAUDE report 15328003 ↗