Regard™ ET00743DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717110804), received between Dec 1, 2021 and Dec 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier.

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. Nov 30, 2021Terminated

   Kits lacks rubber latex warning label.

   Z-0469-2022 · Root cause: Error in labeling · FDA record ↗

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.

• MalfunctionDec 1, 2021Device Markings/Labelling Problem

  ROI CPS, LLC BECAME AWARE, THROUGH AN INTERNAL FINDING THAT THE KIT CONTAINED IN THIS REPORT WAS BUILT WITH A STERILE URETHRAL RED RUBBER CATHETER 12FR, BUT THE LABELING ON THE CUSTOM PROCEDURE KIT DOES NOT INCLUDE THE CAUTION STATEMENT, "CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS." THE URETHRAL RED RUBBER CATHETER 12FR, IS A COMPONENT WITHIN THE CUSTOM PROCEDURE KIT AND IS PACKAGED IN THE ORIGINAL MANUFACTURER PACKAGING (TYVEC POUCH) WHICH INCLUDES THE CAUTION STATEMENT ON THE PRODUCT LABEL, BUT THE CUSTOM PROCEDURE KIT LABELING IS CONSIDERED MISLABELED AS A RESULT OF THE OMISSION OF THE CAUTION STATEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909233 ↗