CARDINAL HEALTH 4850Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20630140019125), received between Dec 23, 2019 and Dec 23, 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

Recent adverse event reports

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

• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT SHOE COVER DURAFIT BLUE 4850 BECOMES VERY SLIPPERY IF THE FLOOR GETS WET ¿FOR WHATEVER REASON¿ AND A SURGICAL TECH FELL ON A WET FLOOR IN FRONT OF THE SCRUB SINK WHILE WEARING THE SHOECOVERS. THE SURGICAL TECH SUFFERED A NEW TEAR LATERAL MENISCUS, LEFT KNEE; MARKED WORSENING OF ANTERIOR CRUCIATE LIGAMENT TEAR; WORSENED PARTIAL THICKNESS TEAR POSTERIOR CRUCIATE LIGAMENT; POSSIBLE TEAR OF MEDIAL CRUCIATE LIGAMENT; WORSENED JOINT EFFUSION AND EDEMA ALONG THE MEDIAL FEMORAL CONDYLE AND TIBIAL PLATEAU. SURGERY WILL BE PROVIDED HOWEVER THE EMPLOYEE IS CONTINUING TO WORK PERFORMING, THE USUAL DUTIES.

  Patient problems: Damage to Ligament(s)

  MAUDE report 9513072 ↗