CARDINAL HEALTH 2202CVRecalls & reported problems
Cardinal Health 200, LLC · Convertors Coverall with Elastic Cuffs and Ankles, XX-Large, White · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 50885380125513), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN EMPLOYEE REPORTED AN ALLERGIC REACTION TO THE EXTERIOR OF THE WHITE COVERALLS. SHE WAS SENT TO HER ALLERGY MD ON (B)(6) 2019.
Patient problems: Skin Irritation
MAUDE report 8552034 ↗
Other Non-surgical isolation gown devices
- CARDINAL HEALTH SBA51FFK14Cardinal Health 200, LLC · Non-surgical isolation gown1 recall0 reports
- NYES Trinity NYES100-2New York Embroidery Studio Inc. · Non-Surgical Gown1 recall0 reports
- Flyte 0408800000NSStryker Corporation · Non-surgical isolation gown1 recall0 reports
- Halyard 69600O&M Halyard, Inc. · Non-surgical isolation gown2 reports
- MEDLINE NONTH150Medline Industries, Inc. · Non-surgical gown1 report
- EndoArmor™ Plus SGE-389-10Boston Scientific Corporation · Non-surgical isolation gown1 report
- MEDLINE NONTH180Medline Industries, Inc. · Non-surgical gown1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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