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FLEXAL 88RT04LRecalls & reported problems

Cardinal Health 200, LLC · Nitrile Exam Gloves Flexal Touch · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20885380157360), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Skin Inflammation/ Irritation1

Recent adverse event reports

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

  • InjuryDec 18, 2020Patient-Device Incompatibility

    BASED ON INFORMATION RECEIVED BY THE CUSTOMER, THE PATIENT REPORTEDLY HAD AN ALLERGIC REACTION TO DIALKYLTHIOREAS. HOSPITAL REPORTED THE INFORMATION TO SEE IF CARDINAL HEALTH GLOVE 88RT04L CONTAINS THIS PRODUCT. THE PATIENT REPORTEDLY WAS GIVEN 50MG OF BENADRYL VIA IV WHILE INTUBATED. THE PATIENT ALLEGEDLY EXPERIENCED HIVES ON THE TORSO AFTER HAVING BEEN TOUCHED BY THE GLOVES.

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 11041476 ↗

Other Patient examination glove, specialty devices

All Patient examination glove, specialty devices →

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