Skip to content

Leg Bag 150319Recalls & reported problems

C. R. Bard, Inc. · Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve and Two Latex Leg Straps, Medium (19oz). · Class 1

All models of Leg Bag (17)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741050794), received between Nov 26, 2017 and Aug 20, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1
  • Fungus in Device Environment1
  • Packaging Problem1
  • Product Quality Problem1
  • Restricted Flow rate1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2020Product Quality Problem; Fungus in Device Environment; Packaging Problem; Fungus in Device Environment

    IT WAS REPORTED THAT THE CUSTOMER BELIEVED THE BAGS RECEIVED FROM LIBERATOR MEDICAL ARE THINNER AND LOWER QUALITY THAN THOSE RECEIVED FROM VITALITY. CUSTOMER ALSO STATED THAT THE PACKAGING MATERIALS WERE LOW GRADE CARDBOARD BOXES AND SUBPAR TAPE WHICH MADE HIM UNCOMFORTABLE OPENING THE BOXES AS THEY COULD BE EXPOSED TO COVID19 VIRUS. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 28JUL2020, ONE OF THE BAGS HAD A MOLD LIKE SUBSTANCE GROWING INSIDE.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 10431829 ↗
  • MalfunctionJun 12, 2020Restricted Flow rate; Restricted Flow rate

    IT WAS REPORTED THAT THE PATIENT HAD A PROBLEM WITH THE ¿FLOATING VALVE¿ AND STATED THAT THE URINE WAS NOT DRAINING INTO THE BAG AND THE TUBING WAS FULL OF URINE, ALSO STATED THAT THE PATIENT WAS IN HOSPITAL AND CATHETERIZED RECENTLY AND EXPERIENCED PAIN AND DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10148031 ↗
  • MalfunctionNov 26, 2017Detachment Of Device Component

    IT WAS REPORTED THAT THE VAPOR LOCK ON THE DRAIN BAG CAUSED THE MALE EXTERNAL CATHETER TO BE PULLED OFF.

    Patient problems: No Information

    MAUDE report 7058310 ↗

Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices

All BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page