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Leg Bag 150919Recalls & reported problems

C. R. Bard, Inc. · Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve, 4-1/2" Drainage Tubing and 2 Fabric Leg Straps and 18" Extension Tubing, Medium (19oz) · Class 1

All models of Leg Bag (17)

Data updated Oct 16, 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 00801741050893), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (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

  • Appropriate Device Problem Term/Code Not Available1
  • Labelling, Instructions for Use or Training Problem1

Patient problems

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

Recent adverse event reports

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

  • MalfunctionJul 20, 2018Labelling, Instructions for Use or Training Problem; Appropriate Device Problem Term/Code Not Available; Labelling, Instructions for Use or Training Problem

    IT WAS REPORTED THAT THE CUSTOMER FOUND THE IFU FOR THE LEG BAG TO BE CONFUSING BECAUSE THE PHOTO OF THE BAG ON THE IFU HAD LEG STRAPS EVEN THOUGH THE LEG BAG IN QUESTION DID NOT COME WITH STRAPS.

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

    MAUDE report 7707885 ↗

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