CONVERTORS 9071ELRecalls & reported problems
Cardinal Health 200, LLC · SmartSleeve Impervious Surgical Gown · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380063428), received between Aug 19, 2021 and Aug 19, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED DURING PROCEDURE THERE WAS A TEAR IN THE SURGICAL TECH¿S GOWN. SLEEVE TEAR WAS FOUND DURING PROCEDURE. NO TREATMENT WAS REQUIRED FOR THE SURGICAL TECH. ADDITIONAL ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT PROPHYLACTICALLY. THE SURGEON GAVE THE PATIENT KEFLEX IRRIGATION BECAUSE OF THIS INCIDENT DUE TO POSSIBLE CONTAMINATION IN ADDITION TO THE CEFAZOLIN THEY RECEIVED FROM ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342394 ↗
Other GOWN, SURGICAL devices
- Medline DYNJP2001SMedline Industries, Inc. · GOWN, SURGICAL2 recalls9 reports
- Medline DYNJP2202SMedline Industries, Inc. · GOWN, SURGICAL2 recalls5 reports
- MEDLINE DYNJP2002SMedline Industries, Inc. · GOWN, SURGICAL2 recalls4 reports
- Medline DYNJP2602Medline Industries, Inc. · GOWN, SURGICAL2 recalls3 reports
- Medline Industries, Inc. DYNJP2402Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- MEDLINE DYNJP2002Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline DYNJP2103Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2203Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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